The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence
2020; 18 (1): 6
Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT.We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool.We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention.Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention.PROSPERO CRD42018098994.
View details for DOI 10.1186/s12916-019-1476-5
View details for Web of Science ID 000513668200001
View details for PubMedID 31955710
View details for PubMedCentralID PMC6970283
Research response to COVID-19 needed better coordination and collaboration: a living mapping of registered trials.
Journal of clinical epidemiology
Researchers worldwide are actively engaging in research activities to search for preventive and therapeutic interventions against COVID-19. Our aim was to describe the planning of randomized controlled trials (RCTs) in terms of timing related to the course of the COVID-19 epidemic and research question evaluated.We performed a living mapping of RCTs registered in the WHO International Clinical Trials Registry Platform. We systematically search the platform every week for all RCTs evaluating preventive interventions and treatments for COVID-19 and created a publicly available interactive mapping tool at https://covid-nma.com to visualize all trials registered.By August 12, 2020, 1,568 trials for COVID-19 were registered worldwide. Overall, the median ([Q1-Q3]; range) delay between the first case recorded in each country and the first RCT registered was 47 days ([33-67]; 15-163). For the 9 countries with the highest number of trials registered, most trials were registered after the peak of the epidemic (from 100% trials in Italy to 38% in the United States). Most trials evaluated treatments (1,333 trials; 85%); only 223 (14%) evaluated preventive strategies and 12 post-acute period intervention. A total of 254 trials were planned to assess different regimens of hydroxychloroquine with an expected sample size of 110,883 patients.This living mapping analysis showed that COVID-19 trials have relatively small sample size with certain redundancy in research questions. Most trials were registered when the first peak of the pandemic have passed.
View details for DOI 10.1016/j.jclinepi.2020.10.010
View details for PubMedID 33096223
View details for PubMedCentralID PMC7575422
Overcoming Barriers to Mobilizing Collective Intelligence in Research: Qualitative Study of Researchers With Experience of Collective Intelligence
JOURNAL OF MEDICAL INTERNET RESEARCH
2019; 21 (7): e13792
Innovative ways of planning and conducting research have emerged recently, based on the concept of collective intelligence. Collective intelligence is defined as shared intelligence emerging when people are mobilized within or outside an organization to work on a specific task that could result in more innovative outcomes than those when individuals work alone. Crowdsourcing is defined as "the act of taking a job traditionally performed by a designated agent and outsourcing it to an undefined, generally large group of people in the form of an open call."This qualitative study aimed to identify the barriers to mobilizing collective intelligence and ways to overcome these barriers and provide good practice advice for planning and conducting collective intelligence projects across different research disciplines.We conducted a multinational online open-ended question survey and semistructured audio-recorded interviews with a purposive sample of researchers who had experience in running collective intelligence projects. The questionnaires had an interactive component, enabling respondents to rate and comment on the advice of their fellow respondents. Data were analyzed thematically, drawing on the framework method.A total of 82 respondents from various research fields participated in the survey (n=65) or interview (n=17). The main barriers identified were the lack of evidence-based guidelines for implementing collective intelligence, complexity in recruiting and engaging the community, and difficulties in disseminating the results of collective intelligence projects. We drew on respondents' experience to provide tips and good practice advice for governance, planning, and conducting collective intelligence projects. Respondents particularly suggested establishing a diverse coordination team to plan and manage collective intelligence projects and setting up common rules of governance for participants in projects. In project planning, respondents provided advice on identifying research problems that could be answered by collective intelligence and identifying communities of participants. They shared tips on preparing the task and interface and organizing communication activities to recruit and engage participants.Mobilizing collective intelligence through crowdsourcing is an innovative method to increase research efficiency, although there are several barriers to its implementation. We present good practice advice from researchers with experience of collective intelligence across different disciplines to overcome barriers to mobilizing collective intelligence.
View details for DOI 10.2196/13792
View details for Web of Science ID 000474337400001
View details for PubMedID 31267977
View details for PubMedCentralID PMC6632103
A scoping review provided a framework for new ways of doing research through mobilizing collective intelligence
JOURNAL OF CLINICAL EPIDEMIOLOGY
2019; 110: 1?11
New forms of research involving collective intelligence (CI) of diverse individuals mobilized through crowdsourcing is successfully emerging in various fields. This scoping review aimed to describe these methods across different fields and propose a framework for implementation.We searched seven electronic databases for reports describing projects that had mobilized CI with crowdsourcing. We used content analysis to develop themes and categories of the methods.We identified 145 reports. CI was mobilized to generate ideas, conduct evaluations, solve problems, and create intellectual outputs. Most projects (n = 110, 76%) were open to the public without restrictions on participants' expertise. Participants contributed to projects by independent contribution (i.e., no interaction with other participants) (n = 50, 34%), collaboration (n = 41, 28%), competitions (n = 33, 23%), and playing games (n = 16, 11%). In total, 61% of articles (n = 89) reported methods to evaluate participants' contribution and decision-making process: 43% used an independent panel of experts and 18% involved end users. We identified challenges in implementation and sustainability of CI and proposed solutions.New research methods based on CI through crowdsourcing could transform clinical research. This framework facilitates the implementation of these methods.
View details for DOI 10.1016/j.jclinepi.2019.02.007
View details for Web of Science ID 000487194400002
View details for PubMedID 30772456