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September 2004, Vol 94, No. 9 | American Journal of Public Health 1476
© 2004 American Public Health Association

LETTER

MOVING BEYOND RANDOMIZED CONTROLLED TRIALS

C. Patrick Chaulk, MD, MPH and Vahé A. Kazandjian, PhD, MPH

C. Patrick Chaulk is with the Annie E. Casey Foundation, Baltimore, Md. Vahé A. Kazandjian is with the Center for Performance Sciences, Elkridge, Md.

Correspondence: Requests for reprints should be sent to C. Patrick Chaulk, MD, MPH, The Annie E. Casey Foundation, 701 St Paul St, Room 425, Baltimore, MD 21202 (e-mail: pchaulk{at}aecf.org).

We concur with Victora et.al.1 and other contributors to the important evaluation issue of the Journal, which highlights a long-standing concern among many in the public health community about the overreliance on randomized controlled trials (RCTs) in research.2 Clearly, RCTs have an important role to play in medical research, although their strength may be limited to assessing well-controlled, narrow interventions, for example, comparing drug A against drug B or procedure A against procedure B. Increasingly, however, public health interventions and the funders who invest in those interventions acknowledge the multifactorial basis of many health outcomes and thus the need for more sophisticated, multidimensional, community-based designs. RCTs have limited capacity to assess such comprehensive initiatives. They also are limited in assessing aspects of quality3 as well as performance measurement.4

If we are to understand the effectiveness of complex community interventions, needed in addition are more robust approaches, ranging from Theory of Change5 to hybrid models combining several traditional approaches,6 modeling, anthropological and sociological tools (focus group dynamics, social network analysis), and syndemic relational analysis.7

Finally, from a population perspective, our experience with immigrants and refugees indicates that trust, choice (patient, family, even community), and client participation are critical prerequisites for successful program design and evaluation.8 Such patient-centeredness is inconsistent with the RCT "randomized and blinded" methodology. Interventions require research designs commensurate with their sophistication.

References

1. Victora CG, Habicht J-P, Bryce J. Evidence-based public health: moving beyond randomized trials. Am J Public Health. 2004;94:400–405.[Abstract/Free Full Text]

2. Practice Guidelines for Public Health: Assessment of Scientific Evidence, Feasibility and Benefits. Albany, NY: Council on Linkages Between Academia and Public Health Practice; October 1995.

3. Kazandjian VA, Matthes N, Wicker KG. Are performance indicators generic? The international experience of the Quality Indicator Project. J Eval Clin Pract. 2003;9:265–276.[ISI][Medline]

4. Kazandjian VA, Lied TR. Healthcare Performance Measurement: Systems Design And Evaluation. Milwaukee, Wisc: ASQ Quality Press; 1999.

5. Change is here. Available at: http://www.theoryofchange.org. Accessed June 27, 2004.

6. Chaulk CP, Grady M. Evaluating tuberculosis control programs: strategies, tools and models. Int J Tuberc Lung Dis. 2000;4(suppl):S55–S66.[Medline]

7. Singer M. A dose of drugs, a touch of violence, a case of AIDS: conceptualizing the SAVA syndemic. Free Inquiry. 1996;24:99–110.

8. Goldberg SV, Wallace J, Jackson JC, Chaulk CP, Nolan CM. Cultural case management of latent tuberculosis infection. Int J Tuberc Lung Dis. 2004;8:76–82.[Medline]





This Article
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