Project description:BackgroundRobust statistical designing, sound statistical analysis, and standardized presentation are important to enhance the quality and transparency of biomedical research. This systematic review was conducted to summarize the statistical reporting requirements introduced by biomedical research journals with an impact factor of 10 or above so that researchers are able to give statistical issues' serious considerations not only at the stage of data analysis but also at the stage of methodological design.MethodsDetailed statistical instructions for authors were downloaded from the homepage of each of the included journals or obtained from the editors directly via email. Then, we described the types and numbers of statistical guidelines introduced by different press groups. Items of statistical reporting guideline as well as particular requirements were summarized in frequency, which were grouped into design, method of analysis, and presentation, respectively. Finally, updated statistical guidelines and particular requirements for improvement were summed up.ResultsTotally, 21 of 23 press groups introduced at least one statistical guideline. More than half of press groups can update their statistical instruction for authors gradually relative to issues of new statistical reporting guidelines. In addition, 16 press groups, covering 44 journals, address particular statistical requirements. The most of the particular requirements focused on the performance of statistical analysis and transparency in statistical reporting, including "address issues relevant to research design, including participant flow diagram, eligibility criteria, and sample size estimation," and "statistical methods and the reasons."ConclusionsStatistical requirements for authors are becoming increasingly perfected. Statistical requirements for authors remind researchers that they should make sufficient consideration not only in regards to statistical methods during the research design, but also standardized statistical reporting, which would be beneficial in providing stronger evidence and making a greater critical appraisal of evidence more accessible.
Project description:ImportanceUsing social media to recruit participants is a common and cost-effective practice. Willingness to participate (WTP) in biomedical research is a function of trust in the scientific team, which is closely tied to the source of funding and institutional connections.ObjectiveTo determine whether WTP and willingness to share social media data are associated with the type of research team and online recruitment platform.Design, setting, and participantsThis mixed-methods longitudinal survey and qualitative study was conducted over 2 points (T1 and T2) using Amazon's Mechanical Turk (MTurk) platform. Participants were US adults aged 18 years or older who use at least 1 social media platform. Recruitment was stratified to match race/ethnicity proportions of the 2010 US Census. The volunteer sample consisted of 914 participants at T1, and 655 participants completed the follow-up survey 5 months later (T2).Main outcomes and measuresOutcomes were (1) past experience with online research and sharing social media data for research; (2) WTP in research advertised online; (3) WTP in a study sponsored by a pharmaceutical company, a university, or a federal agency; and (4) willingness to share social media data. Opinions were solicited regarding the European Union's General Data Protection Regulation statute, which came into effect between T1 and T2.ResultsOf 914 participants completing the first survey (T1), 604 (66.1%) were aged 18 to 39 years and 494 (54.0%) were female. Of these, 655 participants (71.7%) responded at T2. While 680 participants (74.4%) indicated WTP in biomedical research, only 454 (49.3%) were willing to share their social media data. Participants were significantly less likely to participate in federally sponsored (odds ratio [OR], 0.58; 95% CI, 0.51-0.64; P < .001) or pharmaceutical company (OR, 0.59; 95% CI, 0.53-0.66; P < .001) research than university-led studies. They were also less likely to share their social medial data for federal (OR, 0.65; 95% CI, 0.58-0.72; P < .001) or pharmaceutical company (OR, 0.50; 95% CI, 0.44-0.56; P < .001) research compared with academic studies. Willingness to participate in pharmaceutical company-led research decreased 11.89% from T1 to T2 (OR for T2, 0.62; 95% CI, 0.54-0.77; P < .001). Reasons for WTP were interest in furthering science, financial incentives, trust in the organization, and data security. While 63.0% of respondents reported seeing new privacy policy emails related to the General Data Protection Regulation law, only 27.1% indicated this positively influenced their WTP. Thematic analysis of responses indicated that WTP may improve with stronger data security measures.Conclusions and relevanceThis study suggests that researchers may see reduced online research participation and data sharing, particularly for research conducted outside academia.
Project description:Biomedical research networks need to integrate research data among their members and with external partners. To support such data sharing activities, an adequate information technology infrastructure is necessary. To facilitate the establishment of such an infrastructure, we developed a reference model for the requirements. The reference model consists of five reference goals and 15 reference requirements. Using the Unified Modeling Language, the goals and requirements are set into relation to each other. In addition, all goals and requirements are described textually in tables. This reference model can be used by research networks as a basis for a resource efficient acquisition of their project specific requirements. Furthermore, a concrete instance of the reference model is described for a research network on liver cancer. The reference model is transferred into a requirements model of the specific network. Based on this concrete requirements model, a service-oriented information technology architecture is derived and also described in this paper.
Project description:We analysed the Horizon 2020 project database, currently the European Union's (EU) largest framework programme for research and innovation-nearly 80 billion euros available over 7 years (2014-2020), to estimate the amount and type of EU-supported biomedical and health research and funding distribution among EU member states and non-European countries. Out of 20,877 projects as of 14th January 2019, a total of 4865 projects were classified as human health related. Ninety-four countries/territories worldwide participated in at least one biomedical project. The EU-15 original member states showed the highest participation as project leaders/partners and for acquired funding. Strong unequal funding distribution and participation between EU-15 and the 13 newest members-with EU-15 receiving about 87% of funding and EU-13 only 3%-have been evidenced. For both EU-15 and EU-13 we detected about 20% of projects involving the public and private sectors, according to Horizon 2020 guidelines. The largest percentage of projects was in the areas of biotechnological research (28.28%) and "basic research" (26.95%); these two sectors together accounted for 46.99% of the total funding assigned (7.9 billion euros). Research in neurosciences and neurological diseases appeared to be an increasing study area. Neurological and mental diseases covered about 21% of projects. Epidemiological studies accounted for about 5% of the total projects and for 14% of funding. Strong correlations were shown by indicators of financial and scientific capacity to identify success rates in obtaining EU funding, making the gap between countries with strong and weak research infrastructures difficult to overcome.
Project description:IntroductionThe COVID-19 pandemic created an unprecedented need for population-level clinical trials focused on the discovery of life-saving therapies and treatments. However, there is limited information on perception of research participation among perinatal populations, a population of particular interest during the pandemic.MethodsEligible respondents were 18 years or older, were currently pregnant or had an infant (≤12 months old), and lived in Florida within 50 miles of sites participating in the OneFlorida Clinical Research Consortium. Respondents were recruited via Qualtrics panels between April and September 2020. Respondents completed survey items about barriers and facilitators to participation and answered sociodemographic questions.ResultsOf 533 respondents, most were between 25 and 34 years of age (n = 259, 49%) and identified as White (n = 303, 47%) and non-Hispanic (n = 344, 65%). Facebook was the most popular social media platform among our respondents. The most common barriers to research participation included poor explanation of study goals, discomforts to the infant, and time commitment. Recruitment through healthcare providers was perceived as the best way to learn about clinical research studies. When considering research participation, "myself" had the greatest influence, followed by familial ties. Noninvasive biological samples were highly acceptable. Hispanics had higher positive perspectives on willingness to participate in a randomized study (p = 0.009). Education (p = 0.007) had significant effects on willingness to release personal health information.ConclusionWhen recruiting women during the pregnancy and postpartum periods for perinatal studies, investigators should consider protocols that account for common barriers and preferred study information sources. Social media-based recruitment is worthy of adoption.
Project description:BackgroundPatients with advanced disease may not be invited to participate in research based on the assumption that participation would be too burdensome for them. The aim of this study was to explore how patients with advanced disease and their relatives evaluate their experience with research participation.MethodThis study used data from two parts of a larger project. The first dataset was a cross-sectional questionnaire study focused on priorities at the end of life. The second dataset used a longitudinal design with structured interviews on prognostic awareness. In both studies, participants evaluated their experience on a 5-point Likert scale and specified their motivation in an open-ended question. Data were collected in 6 hospitals in the Czech Republic with patients with advanced disease and life expectancy less than 1 year and their relatives. Data were analysed using non-parametric tests and thematic analysis.ResultsFirst dataset consisted of 167 patients and 102 relatives, and second dataset consisted of 135 patients and 92 relatives (in total, 496 respondents). Results were similar in both datasets, with half of the sample (53%, 48%) scoring neutral, and over 30% of the sample identified their experience as interesting. The most significant factors associated with the evaluation were religiosity (p = 0.001) and the type of diagnosis (p = 0.04). Motivation for participation was to improve care, support research, express own opinion, opportunity to talk and trusting relationship.ConclusionsPatients with advanced disease and relatives do not mind participating in palliative care research, and it can be even a positive experience for them.
Project description:BackgroundBlack breast and ovarian cancer patients are underrepresented in clinical cancer trials disproportionate to the prevalence of these cancers in Black females. Historically, lower enrollment has been attributed to individualized factors, including medical mistrust, but more recently structural factors, including systemic racism, have received additional scrutiny. We interviewed Black women with a personal or family history of breast and ovarian cancer to understand their views and experiences related to research participation.MethodsQualitative interviews were conducted via telephone or video conference and transcribed verbatim. Transcripts were qualitatively analyzed for iterative themes related to the offer and participation in cancer clinical trials and research studies, impact on cancer care, and recommendations to increase enrollment of Black patients.ResultsSixty-one Black women completed an interview. Participants expressed that Black women are underrepresented in cancer research, and that this negatively impacted their own care. Many cited past historical abuses, including the Tuskegee syphilis trial, as a potential factor for lower enrollment but suggested that lower enrollment was better understood in the context of the entirety of their healthcare experiences, including present-day examples of patient mistreatment or dismissal. Participants suggested that proactive community engagement, transparency, and increased representation of Black research team members were strategies likely to foster trust and bolster research participation.Conclusion(s)Medical mistrust is only a partial factor in the lower participation of Black patients in cancer research. Researchers should implement the strategies identified by our participants to promote diverse enrollment and ensure that Black patients are included in future therapeutic advances.
Project description:BackgroundThe Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial.MethodsWe conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis.ResultsTwenty-three women who gave either written consent (n = 18) or oral assent followed by written consent (n = 5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women's minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women's understanding of the trial and intervention, regardless of the consent pathway.ConclusionsOverall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited.Trial registrationISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.
Project description:The Kansas IDeA Network of Biomedical Research Excellence (K-INBRE) was established in 2001 and is a network of 10 higher-education institutions in Kansas and northern Oklahoma. The program is funded by the Institutional Development Award (IDeA) program of the National Institutes of Health (NIH). As part of the program's goal to enhance the research infrastructure in Kansas, a training program was developed to encourage undergraduates to participate in biomedical research. From September 2002 to May 2012, the K-INBRE supported 731 students at 10 institutions. Although 16% of student participants in the program are still undergraduates, 323 of our students have gone into biomedical graduate school or medical school programs. Thirty-seven percent of all the completed students have matriculated into graduate programs and 19% of our completed students went to medical school. Moreover, 12% have gone into other health-related professions. One percent of our students who went into medical school programs are in highly prestigious MD/PhD programs. In the fall of 2011, we surveyed participants from the last 10 years about career choices and the impact of the K-INBRE program on those students. Two hundred twenty-four former and current students responded to the survey with a consensus of high impact of the K-INBRE program on student training, career choices, and perceptions about research.
Project description:In rural, Indigenous Guatemala, women's healthcare is fragmented and inadequate. Our interdisciplinary, multinational research team aimed to 1) describe reproductive health in one rural Indigenous community; 2) explore contraceptive use; and 3) learn about and prioritize Indigenous Maya women's reproductive health beliefs and needs. Our study team conducted mixed-methods surveys with 62 women, led focus groups with 20 community health workers, and analyzed data using concurrent mixed methods analysis. We found that 51% of women surveyed reported current family planning, with 33% using a biomedical method. We found high mean fertility, 6.9 live births per woman aged 40-49 (national average 4.7), with significant socioeconomic variation. We also found that poverty correlated with total fertility, while education inversely correlated. Our research found that contraceptive use had a strong association with access to healthcare and with women's reported sexual autonomy (which we instrumentalized based on women's answers to the question "can you refuse to have sex with your husband?"). Many women we spoke to feared contraception, specifically concerned it could cause cancer. Overall, Guatemalan Indigenous women expressed unease seeking reproductive healthcare within health systems that have historically and currently excluded and mistreated Indigenous communities. Our research documented unexplored influences on contraceptive use, including the relationship between sexual autonomy and contraception and widespread concern of cancer with contraceptive use. We conclude, moving forward, that we and other researchers should continue to collaborate with communities to improve Indigenous women's reproductive healthcare.