Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework

Nienke Bleijenberg; Janneke M de Man-van Ginkel; Jaap C A Trappenburg; Roelof G A Ettema; Carolien G Sino; Noor Heim; Thóra B Hafsteindóttir; David A Richards; Marieke J Schuurmans

doi:10.1016/j.ijnurstu.2017.12.001

Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework

Int J Nurs Stud. 2018 Mar:79:86-93. doi: 10.1016/j.ijnurstu.2017.12.001. Epub 2017 Dec 5.

Authors

Nienke Bleijenberg¹, Janneke M de Man-van Ginkel², Jaap C A Trappenburg³, Roelof G A Ettema⁴, Carolien G Sino⁵, Noor Heim⁶, Thóra B Hafsteindóttir⁷, David A Richards⁸, Marieke J Schuurmans⁹

Affiliations

¹ University Medical Center Utrecht, Department Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands; University of Applied Sciences Utrecht, Institute of Nursing Studies, Research group Care for the Chronically Ill and Elderly, The Netherlands. Electronic address: [email protected].
² University Medical Center Utrecht, Department Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands. Electronic address: [email protected].
³ University Medical Center Utrecht, Department Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands; University of Applied Sciences Utrecht, Institute of Nursing Studies, Research group Care for the Chronically Ill and Elderly, The Netherlands. Electronic address: [email protected].
⁴ University of Applied Sciences Utrecht, Institute of Nursing Studies, Research group Care for the Chronically Ill and Elderly, The Netherlands. Electronic address: [email protected].
⁵ University of Applied Sciences Utrecht, Institute of Nursing Studies, Research group Care for the Chronically Ill and Elderly, The Netherlands. Electronic address: [email protected].
⁶ University Medical Center Utrecht, Department Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands. Electronic address: [email protected].
⁷ University Medical Center Utrecht, Department Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands; University of Applied Sciences Utrecht, Institute of Nursing Studies, Research group Care for the Chronically Ill and Elderly, The Netherlands. Electronic address: [email protected].
⁸ University of Exeter Medical School, Institute of Health Research, Exeter, United Kingdom. Electronic address: [email protected].
⁹ University Medical Center Utrecht, Department Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht University, The Netherlands; University of Applied Sciences Utrecht, Institute of Nursing Studies, Research group Care for the Chronically Ill and Elderly, The Netherlands. Electronic address: [email protected].

PMID: 29220738
DOI: 10.1016/j.ijnurstu.2017.12.001

Abstract

Background: In recent years there has been much emphasis on 'research waste' caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial.

Objective: We therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practice METHODS: Based on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed. Examples from published reports are presented to illustrate the methodology that can be applied within each element to enhance the intervention design.

Results: A comprehensive iterative approach is presented by combining the elements of the MRC Framework development phase with essential elements from existing guidance including: problem identification, the systematic identification of evidence, identification or development of theory, determination of needs, the examination of current practice and context, modelling the process and expected outcomes leading to final element: the intervention design. All elements are drawn from existing models to provide intervention developers with a greater chance of producing an intervention that is well adopted, effective and fitted to the context.

Conclusion: This comprehensive approach of developing interventions will strengthen the internal and external validity, minimize research waste and add value to health care research. In complex interventions in health care research, flaws in the development process immediately impact the chances of success. Knowledge regarding the causal mechanisms and interactions within the intended clinical context is needed to develop interventions that fit daily practice and are beneficial for the end-user.

Keywords: Complex interventions; Guidance; Intervention development; MRC framework; Methodology.

MeSH terms

Biomedical Research*
Waste Management / methods*