Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach

This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review. Objective To identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation. Design Systematic review. Data sources The Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied. Study selection Randomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility. Results 45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95% CI 1.09 to 1.36; two studies, 4833 participants). However, the effect of many other strategies is less clear, including the use of video to provide trial information and interventions aimed at recruiters. Conclusions There are promising strategies for increasing recruitment to trials, but some methods, such as open-trial designs and opt-out strategies, must be considered carefully as their use may also present methodological or ethical challenges. Questions remain as to the applicability of results originating from hypothetical trials, including those relating to the use of monetary incentives, and there is a clear knowledge gap with regard to effective strategies aimed at recruiters.

The business community has learned the value of design thinking as a way to innovate in addressing people's needs--and health systems could benefit enormously from doing the same. This paper lays out how design thinking applies to healthcare challenges and how systems might utilize this proven and accessible problem-solving process. We show how design thinking can foster new approaches to complex and persistent healthcare problems through human-centered research, collective and diverse teamwork and rapid prototyping. We introduce the core elements of design thinking for a healthcare audience and show how it can supplement current healthcare management, innovation and practice.

Introduction Applying Design Thinking to health care could enhance innovation, efficiency, and effectiveness by increasing focus on patient and provider needs. The objective of this review is to determine how Design Thinking has been used in health care and whether it is effective. Methods We searched online databases (PubMed, Medline, Web of Science, CINAHL, and PyscINFO) for articles published through March 31, 2017, using the terms “health,” “health care,” or “healthcare”; and “Design Thinking,” “design science,” “design approach,” “user centered design,” or “human centered design.” Studies were included if they were written in English, were published in a peer-reviewed journal, provided outcome data on a health-related intervention, and used Design Thinking in intervention development, implementation, or both. Data were collected on target users, health conditions, intervention, Design Thinking approach, study design or sample, and health outcomes. Studies were categorized as being successful (all outcomes improved), having mixed success (at least one outcome improved), or being not successful (no outcomes improved). Results Twenty-four studies using Design Thinking were included across 19 physical health conditions, 2 mental health conditions, and 3 systems processes. Twelve were successful, 11 reported mixed success, and one was not successful. All 4 studies comparing Design Thinking interventions to traditional interventions showed greater satisfaction, usability, and effectiveness. Conclusion Design Thinking is being used in varied health care settings and conditions, although application varies. Design Thinking may result in usable, acceptable, and effective interventions, although there are methodological and quality limitations. More research is needed, including studies to isolate critical components of Design Thinking and compare Design Thinking–based interventions with traditionally developed interventions.