We foresee an increasing role for the stepped wedge cluster randomized trial design
in child health services research. Although a recent systematic review only identified
25 such studies,
1
those studies offer themselves as compelling examples to consider. As we will demonstrate,
the stepped wedge cluster randomized trial is particularly apt as a research design
for health services research. Furthermore, the stepped wedge cluster randomized trial
is particularly attractive for health services research concerning children and adolescents
because its design addresses problems that complicate child health services research
and differentiate those efforts from adult health services research.
2
,
3
,
4
In this narrative review, we illustrate how cluster randomized trials in general
address those problems and how the particular form of the stepped wedge cluster randomized
trial works to offer additional advantage.Raphael J, Sadof M, Stille C, et al. Not just little adults: considerations for quality measures of child health care. National Quality Measures Clearinghouse. Available at: http://www.qualitymeasures.ahrq.gov/expert/expert-commentary.aspx?id=47906. Accessed April 28, 2014.
Keywords
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References
- Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation.J Clin Epidemiol. 2011; 64: 936-948
- Outcomes research in pediatric settings: recent trends and future directions.Pediatrics. 2003; 111: 171-178
- The family-centered medical home: specific considerations for child health research and policy.Acad Pediatr. 2010; 10: 211-217
Raphael J, Sadof M, Stille C, et al. Not just little adults: considerations for quality measures of child health care. National Quality Measures Clearinghouse. Available at: http://www.qualitymeasures.ahrq.gov/expert/expert-commentary.aspx?id=47906. Accessed April 28, 2014.
- The C.A.S.E. approach: guidance for talking to vaccine-hesitant parents.Minn Med. 2013; 96: 49-50
- Making the C.A.S.E. for the human papillomavirus vaccine: how to talk to parents and adolescents.Minn Med. 2014; 97: 38-42
- Treatment allocation in trials: cluster randomisation.BMJ. 2014; 348: g2820
- Step-wedge cluster-randomised community-based trials: an application to the study of the impact of community health insurance.Health Res Policy Syst. 2008; 6: 10
- The effect of a complementary e-learning course on implementation of a quality improvement project regarding care for elderly patients: a stepped wedge trial.Implement Sci. 2012; 7: 13
Hughes J, Goldenberg RL, Wilfert CM, et al. Design of the HIV Prevention Trials Network (HPTN) protocol 054: a cluster randomized crossover trial to evaluate combined access to Nevirapine in developing countries. Working Paper 195. UW Biostatistics Working Paper Series; March 2003.
- Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol.BMC Geriatr. 2011; 11: 25
- Selection bias versus allocation bias.BMJ. 2013; 346: f3345
- Assessing participation bias in a population-based study of measles–mumps–rubella vaccine immunity in children and adolescents aged 12–18.Paediatr Perinat Epidemiol. 2007; 21: 376-384
- The influence of screening on the incidence of ruptured abdominal aortic aneurysms.J Vasc Surg. 1999; 30: 203-208
- Improved Delivery of Cardiovascular Care (IDOCC) through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care.Implement Sci. 2011; 6: 110
- Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial.BMC Public Health. 2010; 10: 738
- Unit of observation versus unit of analysis.BMJ. 2014; 348: g3840
- Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.JAMA. 2003; 290: 1624-1632
- Quasi-Experimentation: Design and Analysis Issues for Field Settings.Houghton Mifflin Company, Boston, Mass1979
- The Gambia Hepatitis Intervention Study.Cancer Res. 1987; 47: 5782-5787
- Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol.BMC Health Serv Res. 2012; 12: 22
- Comparison of home-based therapy with ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial.Am J Clin Nutr. 2005; 81: 864-870
- A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology–based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: the DQIP study protocol.Implement Sci. 2012; 7: 24
- Implementing the chronic care model for frail older adults in the Netherlands: study protocol of ACT (frail older Adults: Care in Transition).BMC Geriatr. 2012; 12: 19
- Act in case of depression: the evaluation of a care program to improve the detection and treatment of depression in nursing homes. Study protocol.BMC Psychiatry. 2011; 11: 91
- A knowledge translation collaborative to improve the use of therapeutic hypothermia in post–cardiac arrest patients: protocol for a stepped wedge randomized trial.Implement Sci. 2011; 6: 4
- Design and analysis of stepped wedge cluster randomized trials.Contemp Clin Trials. 2007; 28: 182-191
- What is an intracluster correlation coefficient? Crucial concepts for primary care researchers.Ann Fam Med. 2004; 2: 204-208
- Stepped wedge cluster randomized trials are efficient and provide a method of evaluation without which some interventions would not be evaluated.J Clin Epidemiol. 2013; 66: 1058-1059
- The stepped wedge trial design: a systematic review.BMC Med Res Methodol. 2006; 6: 54
- Supplemental feeding with ready-to-use therapeutic food in Malawian children at risk of malnutrition.J Health Popul Nutr. 2005; 23: 351-357
- Adaptive trials in clinical research: scientific and ethical issues to consider.JAMA. 2012; 307: 2379-2380
President’s Council of Advisors on Science and Technology. Report to the president on propelling innovation in drug discovery, development, and evaluation. September 2012. Available at: http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fda-final.pdf. Accessed November 9, 2014.
- The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees.BMJ. 2013; 346: f2838
- Emergent literacy intervention for prekindergarteners at risk for reading failure.J Learn Disabil. 2009; 42: 336-355
Article Info
Publication History
Published online: January 20, 2015
Accepted:
October 26,
2014
Received:
November 14,
2013
Footnotes
The authors declare that they have no conflict of interest.
Identification
Copyright
© 2015 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.
