Nelofar Kureshi MD, MHI.
Clinical Researcher and Case Manager
Rupert Case Management Inc.
Agile Science and Research
Traditionally, software development has followed a sequential design process or waterfall model, in which events occur progressively through various phases. The original waterfall model was conceptualized by Winston W. Royce in 1970, where he described seven phases of development: requirements specification, design, construction, integration, testing/debugging, installation and maintenance. In his article, Royce did not use “waterfall” to describe the flow of events, but provided a critical view of the shortcomings in sequential design. The waterfall approach is a dicey and high-priced method to build software-an overwhelming number of waterfall-style projects fail either because the systems do not meet the real needs of clients or require extensive rework to be usable. These failures have led to the proposal and development of agile methodology as an alternative to sequential design.
The values and principles of agile development are specified in the Manifesto for Agile Software Development:
Individuals and interactions over processes and tools
Working software over comprehensive documentation
Customer collaboration over contract negotiation
Responding to change over following a plan
That is, while there is value in the items on
the right, we value the items on the left more.
Agile methodology supports adaptability in which iterative workflow and development is key. In each iteration, various phases of development such as requirements, design and testing often occur simultaneously. Feedback over time-boxed intervals allows the adaptation of new ideas and changes to occur easily. This is in contrast to the waterfall method, whose linear nature makes it impossible to return to a completed stage and changing the final product means developing new code from the beginning.
The integration of agile methodology with scientific methodology stems from the inherent similarity between the two approaches. Scientific methodology follows an iterative approach involving hypothesis formation, testing, and analysis.
Dr. Eric Hekler defines agile science as the exploration of “scientific methods and processes to solve complex societal problems (e.g., health, environmental sustainability, economic and political stability) to make science socially relevant and expedient.
Agile Science Values and Principles are:
Relevance and social value over pure academic pursuit
Outputs as non-technical insights, tools, and solutions over outputs as publications
Iterative experimentation over long time-scale, pre-planned research
Openness and sharing over knowledge as property
Interdisciplinary teamwork and community engagement over siloed expertise
Fiscal sustainability over fiscal disconnect
Two well studied eHealth rapid research design methods that utilize the agile science values are Multiphase Optimization Strategy (MOST) and Sequential Multiple Assignment Randomized Trial (SMART).
Randomized controlled trials (RCT) are the gold standard for assessing the effect of interventions. Post hoc analyses evaluate the outcomes of the intervention and can be used to refine and modify the program, which is then assessed by a new RCT. 1 The flaw in this approach, 2 is that the analysis evaluates the RCT intervention as a whole and does not take into account any individual components. MOST is an alternative to the traditional RCT approach and consists of three stages: screening, refining and confirming. In the screening phase program and delivery components that are to be retained or discarded are ascertained. These components represent the initial version of the intervention. In the refining phase, the first draft interventions are refined further using randomized experimentation. In the final phase of confirming, the optimized intervention is evaluated in a standard RCT. 1
The SMART approach is an experimental design for developing adaptive intervention strategies which are a sequence of decision rules that specify how the treatment intensity should change depending on a patient’s requirements. Adaptive interventions from SMART allow the dynamic tailoring of treatment for evolving response of participants. 3
Traditional research approaches for translating research into practice are painstakingly slow, estimated to take 15-20 years. MOST and SMART are two agile scientific methods that present rapid and efficient evaluation of interventions and subsequent implementation into clinical use.
1 Collins, LM, Murphy, SA, Strecher, V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. American journal of preventive medicine, 2007; 32(5): S112-S118.
2 Collins, LM, Murphy, SA, Nair, VN, Strecher, VJ. A strategy for optimizing and evaluating behavioral interventions. Annals of Behavioral Medicine, 2005;30(1): 65-73
3 Almirall, D, Compton, SN, Gunlicks‐Stoessel, M, Duan, N, Murphy, SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Statistics in Medicine, 2012; 31(17), 1887-1902.