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Editorial | 1353
EDITORIAL
intervention integrity is dened as the evidence of t with the theory or principles of the hypothesized change process.7(p1563) There is obvious merit to freeing the RCT from a literal denition of standardization-as-repetition of the same activities across diverse communities. However, the Hawe et al. worldview from which the form and function distinction ows is one that regards community interventions as complex rather than simple.7 Whereas simple interventions are conceptualized as the sum of their discrete parts or core components, complex interventions rest on systems theory perspectives that address interactive functions rather than core components and ripple effects of interventions including, but going beyond, individuals. Here, reducing a complex system to its component parts amounts to irretrievable loss of what makes it a system.7(p1561) Applying this perspective to translational research raises important questions about the concept of core components. First, they are neither easy to identify nor isolate as independent contributors to outcomes.7 The DPP, for example, was not designed to test the relative contributions of dietary changes, increased physical activity, and weight loss to the reduction of risk in diabetes.8(p398) Rather, it was planned to assess the combined effects of the intervention components addressing these different outcomes. How these components combined, or how they may combine in different contexts or with different populations, is unknown. More fundamentally, the Hawe et al. perspective begins with theorizing principles of change, mechanisms, or mediators of intended outcomes, and translating those principles into forms that may
vary across contexts. In the translational example in Katz et al., the core (xed) components are conceptualized as forms rather than functions. The participatory task is to gure out how the function they presumably serve can be translated. But starting with the form rather than the function reverses the process suggested by Hawe et al. and seemingly assumes that forms or core components serve the same function across communities but need to be tailored to local context. A focus on function at the outset of the translation process would complicate greatly the notion of core components and the science behind it. For the translation of the 16-session curriculum of the DPP, for example, a discussion of function in diverse communities may result in varying the length or content of a prescribed curriculum, or it may imply developing something other than a curriculum to fulll the same function in different communities. In CBPR terms, the greater the emphasis on form, the less formative the local inuence on translation, and the greater the emphasis on function, the stronger the local inuence is, but the issue of delity as traditionally dened becomes more imperative. Katz et al.s concern about local inuence diluting the generalizabilty of interventions reoccurs in the translation process if Hawe et al. are to be taken seriously.
conditions ndings were generated, and how do the ndings apply to the local community. The DPP screened over 158 000 individuals to achieve a nal sample of 3234,9 with most exclusion criteria . . . chosen to reduce the risk of adverse effects of the intervention.9(p624) The implications of such selectivity needs to be claried for local participating organizations not only as a translation issue but as an ethical issue of not overstating what we know about for whom the intervention has shown efcacy. However, translational research, in addition to issues of local acceptability and commitment, also involves an assessment of resources necessary to translate and sustain the intervention. The high impact arm of the DPP included an elaborate recruitment process, culturally tailored dietary and exercise components, a 16-session core curriculum delivered by trained case managers, an exercise regimen of 150 minutes per week,9 and additional staff to monitor adherence and retention.10 These are all part of what it took to get the intervention effect. The lack of take of the DPP program cited in Katz et al. may be inuenced less by lack of community involvement than by the scope of needed resources. Scientic humility about the generalizability of externally derived and candid assessments with local portals on the resources necessary to conduct and sustain such an effort would seem to be a prime topic for important local input in translational research. The CBPR worldview includes thinking systemically and contextually. It addresses sustainability through such goals as capacity building and empowerment. The form versus function distinction of Hawe et al. likewise conceptualizes
interventions as complex and the intervention process as systemic. The Katz et al. article operates on a quite different paradigm that focuses on intervention as simple with xed components, and views the intervention as the technology rather than an event in a system with multiple outcomes and interactive rather than additive aspects.10 In these areas the CBPR worldview differs fundamentally with the worldview as portrayed in Katz et al. and in the DPP example and is subservient to it. As Katz et al. point out, the adaptive requirements for investigators to secure external funding often set constraints on the degree to which local participation can meaningfully contribute to the co-creation of locally relevant interventions. We need more conversations about moving translational research beyond the image of community interventions as product development and product dissemination. The Katz et al. article serves this very important function. j
Acknowledgments
The author wishes to thank Kenneth McLeroy for comments on versions of this editorial.
References
1. Minkler M, Wallerstein N, eds Community-Based Participatory Research in Health. 2nd ed. San Francisco, CA: JosseyBass; 2008.
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2. Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Annu Rev Public Health. 1998;19:173---202. 3. Katz DL, Murimi M, Gonzalez A, Njike V, Green LW. From controlled trial to community adoption: the Multisite Translational Community Trial. Am J Public Health. 2011;101(8):e17---e27. 4. Mohatt GV, Hazel KL, Allen J, et al. Unheard Alaska: culturally anchored participatory action research on sobriety with Alaska Natives. Am J Community Psychol. 2004;33:263---273. 5. Eng E, Hatch J, Callan A. Institutionalizing social support through the church and into the community. Health Educ Behav. 1985;12(1):81---92. 6. Schensul JJ. Sustainability in HIV prevention research. In: Trickett EJ, Pequegnat W, eds Community Interventions and AIDS. New York, NY: Oxford University Press; 2005:176---195. 7. Hawe P, Shiell A, Riley T. Complex interventions: how far out of control should a randomised controlled trial be? BMJ. 2004;328:1561---1563. 8. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393---403. 9. The Diabetes Prevention Program Research Group. The Diabetes Prevention Program: baseline characteristics of the randomized cohort. Diabetes Care. 2000;23:1619---1629. 10. The Diabetes Prevention Program Research Group. The Diabetes Prevention Program: design and method for a clinical trial in the prevention of type 2 diabetes. Diabetes Care. 1999;22(4): 623---634.
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