Dataset Information

Streamlined mail-based methods for large randomised trials: lessons learnt from the ASCEND study.

ABSTRACT: Reliable assessment of the effects of an intervention usually requires large randomised trials but such studies are becoming increasingly complex and costly to run. 'Streamlined' trials are needed in which every aspect of the trial design and conduct is simplified, retaining only those elements needed to answer the research question and ensure the safety of the individual participants. In this review we discuss how the trial 'A Study of Cardiovascular Events iN Diabetes' (ASCEND) was streamlined. The study included a two-by-two factorial design: it assessed the effects of low-dose aspirin and, separately, supplementation with n-3 fatty acids on serious vascular events in 15,480 people with diabetes but no overt cardiovascular disease. Other key streamlined design features, such as mail-based recruitment and follow-up, mainly by post, with no in-person visits and use of a run-in period, are also described. We go on to discuss the success of the study and other studies that have employed a similar mail-based approach, and the type of clinical trials that are suitable for mail-based design. Finally, we consider the limitations of the study, and how these could be circumvented in future studies. ASCEND randomised large numbers of eligible participants, achieved good adherence rates and almost complete follow-up at a fraction of the cost of traditional clinic-based trials. Such studies are necessary if researchers are to address the important clinical questions most relevant to improving health.

SUBMITTER: Mafham MM

PROVIDER: S-EPMC7145772 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Streamlined mail-based methods for large randomised trials: lessons learnt from the ASCEND study.

Mafham Marion M MM Bowman Louise J LJ Haynes Richard J RJ Armitage Jane M JM

Diabetologia 20191130 5

Reliable assessment of the effects of an intervention usually requires large randomised trials but such studies are becoming increasingly complex and costly to run. 'Streamlined' trials are needed in which every aspect of the trial design and conduct is simplified, retaining only those elements needed to answer the research question and ensure the safety of the individual participants. In this review we discuss how the trial 'A Study of Cardiovascular Events iN Diabetes' (ASCEND) was streamlined ...[more]

PMID: 31786655

Similar Datasets

Project description:BackgroundSimulation based medical education (SBME) allows learners to acquire clinical skills without exposing patients to unnecessary risk. This is especially applicable to Emergency Medicine training programs where residents are expected to demonstrate proficiency in the management of time critical, low frequency, and highly-morbidity conditions. This study aims to describe the process through which a SBME curriculum was created, in a limited simulation resource setting at a 4-year Emergency Medicine (EM) residency program at the American University of Beirut Medical Center.MethodsA case-based pilot simulation curriculum was developed following Kern's 6 step approach to curriculum design. The curricular objectives were identified through an anonymous survey of the program's residents and faculty. Curriculum outcomes were assessed, and the curriculum was revised to address curricular barriers. Evaluations of the revised curriculum were collected during the simulation sessions and through a whole revised curriculum evaluation at the end of the first year of its implementation.Results14/20 residents (70%) and 8/8 faculty (100%) completed the needs assessment from which objectives for the pilot curriculum were developed and implemented through 6 2-h sessions over a 1-year period. Objectives were not met and identified barriers included cost, scheduling, resources, and limited faculty time. The revised curriculum addressed these barriers and 24 40-min sessions were successfully conducted during the following year. The sessions took place 3 at a time, in 2-h slots, using the same scenario to meet the objectives of the different learners' levels. 91/91 evaluations were collected from participants with overall positive results. The main differences between the pilot and the revised curricula included: a better understanding of the simulation center resources and faculty's capabilities.ConclusionSimulation-based education is feasible even with limited-resources. However, understanding the resources available, and advocating for protected educator time are essential to implementing a successful EM simulation curriculum.

Project description:BackgroundDespite having many advantages, online eHealth trials are not without challenges-notably, participant recruitment, and outcome data retention. Moreover, publications from these trials rarely provide detailed information on the methods used for recruitment and retention or discuss implications of the methods for future studies.ObjectiveTo address this need for empirical guidance regarding recruitment and outcome data retention planning, we aim to describe the methods and lessons learned from the recruitment and retention procedures used in a large randomized trial of 2 Web-based smoking cessation interventions.MethodsTo ensure a demographically and geographically diverse participant sample, we used the recruitment strategies (1) traditional, (2) Web-based, and (3) online survey panel methods and adaptively modified each in response to recruitment success. At baseline, participants indicated how they heard about the study and answered demographic questions. To maximize trial retention at each of the 3-, 6-, and 12-month assessment points, 4 survey modalities (first Web, followed by phone, mail, and postcard) were sequentially timed over a 30-day period. Participants received US $25 for submitting their responses, regardless of modality, and received an additional US $10 bonus for completing the Web survey within 24h of electronic notification.ResultsWe randomized 2637 smokers in 16 months and achieved 88% retention at 12-months. Participants (79.26% female, 72.60% Caucasian) were recruited from all 50 states. The majority of participants were recruited through Facebook (49.43%), followed by the survey panel (20.85%), free internet sources (14.54%), traditional media (11.34%), and Google ads (3.84%). Descriptively, participant demographics varied by recruitment source. Of the completed follow-up surveys, most were completed by Web (92%). Retention rates did not vary by recruitment source.ConclusionsContinuous monitoring and refinement of multiple recruitment methods, particularly of online advertising campaigns, allowed us to maximize the effectiveness of recruitment strategies in recruiting a large, diverse sample of smokers. Likewise, offering multiple follow-up survey modalities in sequential order along with time-dependent bonus incentives enabled us to obtain outcome data from a very high level of enrolled participants for the duration of the trial protocol. These strategies may be similarly useful in other trials.Trial registrationClinicalTrials.gov NCT01812278; https://clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/71gy5GLvO).

Dataset Information

Streamlined mail-based methods for large randomised trials: lessons learnt from the ASCEND study.

Publications

Streamlined mail-based methods for large randomised trials: lessons learnt from the ASCEND study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets