Moving from efficacy to effectiveness trials in prevention research

Efficacy trials test whether interventions work under optimal, highly controlled conditions whereas effectiveness trials test whether interventions work with typical clients and providers in real-world settings. Researchers, providers, and funding bodies have called for more effectiveness trials to understand whether interventions produce effects under ecologically valid conditions, which factors predict program effectiveness, and what strategies are needed to successfully implement programs in practice settings. The transition from efficacy to effectiveness with preventive interventions involves unique considerations, some of which are not shared by treatment research. The purpose of this article is to discuss conceptual and methodological issues that arise when making the transition from efficacy to effectiveness research in primary, secondary, and tertiary prevention, drawing on the experiences of two complimentary research groups as well as the existing literature. We address (a) program of research, (b) intervention design and conceptualization, (c) participant selection and characteristics, (d) providers, (e) context, (f) measurement and methodology, (g) outcomes, (h) cost, and (i) sustainability. We present examples of research in eating disorder prevention that demonstrate the progression from efficacy to effectiveness trials.     

Moving from cognition to behavior: What the research says

In 1994, R. G. Lord and P. E. Levy proposed a variant of control theory that incorporated human information processing principles. The current article evaluates the empirical evidence for their propositions and updates the theory by considering contemporary research on information processing. Considerable support drawing from diverse literatures was found for propositions concerning the activation of goal-relevant information, the inhibition of goal-irrelevant information, and the consequences of goal completion. These effects were verified by meta-analytic analyses, which also supported the meaningfulness of such effects on the basis of their unstandardized magnitudes. The authors conclude by proposing new directions for this version of control theory by invoking recent theorizing on goal emergence and the importance of velocity and acceleration information for goal striving and by reviewing research in cognitive neuroscience.     

NICHD research initiative in newborn screening

Recent changes in genetics research have created new opportunities to improve the scope and quality of newborn screening services. Changes in newborn screening should be supported and directed by an organized program of research. The NICHD Research Initiative in Newborn Screening includes the development of systematic methods to identify additional conditions appropriate for newborn screening; development and testing innovative interventions and treatments to improve outcomes; education of the provider workforce; development and implementation of appropriate information and communication systems for parents and providers; and, sponsoring an ongoing program of research and research training. Future needs will include the development of a national translational research infrastructure, prevention research and research into behavioral and social sciences issues. The NICHD Research Initiative in Newborn Screening is expected to be an ongoing and vital initiative that adapts itself to new scientific findings, technological developments, changes in the public and personal health care system, and our evolving understanding of the needs of affected individuals, families and the community.     

Long-term care reform: An analysis of the proposed federal initiative for long-term care channeling centers

This article investigates alternatives to the current long-term health care system whereby clients would be channeled to appropriate services through community-based long-term care centers. Specifically, it examines whether the federal government should encourage initiatives to develop such a system and reviews three alternative proposals for accomplishing this.     

Single-participant research design. Bringing science to managed care

The ongoing transition to managed health care continues to have repercussions for health care providers, perhaps the most important of which is an emphasis on accountability for demonstrating the usefulness of clinical interventions. This requirement places a premium on intervention research and highlights the historically strained relationship between psychological research and professional practice. In the midst of this challenge, researchers have increasingly criticized the logic and practice of traditional null hypothesis significance testing. This article describes the history, epistemology, and advantages of single-participant research designs for behavioral scientists and professionals in clinical settings. Although its lack of correspondence with the Fisherian tradition has precluded widespread adoption, the single-participant alternative features a design power and flexibility well suited to both basic science and applied research.     

Moving from Principles to Practice: Recommended Policy Changes to Promote Family-Centered Care

This paper emphasizes the value of family-centered care. Discussion highlights family-centered philosophies (e.g., Systems of Care [SOCs]) and practice models (i.e., wraparound) and identifies discrepancies between conceptualizations and actual practice. Data from multiple sources detail issues in fidelity to family-centered values and needs and risks experienced by siblings of children with severe emotional disturbance and their caregivers. This discussion provides a springboard for policy recommendations to strengthen family support programming and enhance family-centered care, from modifying funding streams such that systems extend their reach beyond children with full-blown, diagnosable problems (those meeting standards of "medical necessity), to supporting prevention and early intervention initiatives that address families as targets for intervention. Recommendations include ensuring that communities with SOC funding address the needs of families; broadening Medicaid rules and definitions; expanding the range of reimbursable activities and services; and increasing funding for evaluating family-centered care models and family support programming.     

Autism: from research to practice

Autism is the most commonly studied of a spectrum of developmental disorders that are believed to be neurobiologically based but which, at this point, for lack of good biomarkers, are defined purely by behavior. In the last 20 years, the definition of autism has shifted in emphasis from extreme aloofness and positive signs of abnormality in repetitive and sensorimotor behaviors to a greater awareness of the importance of more subtle reciprocal social communication deficits as core features. Standard diagnostic instruments were developed for research purposes to acquire information both through caregiver interviews and direct clinical observation. Use of these instruments in clinical practice resulted in major improvements, which in turn affected research results. These results yielded further improvements that led to changes in clinical practice over time. The synergism between research and clinical practice in the understanding of autism is discussed.     

The right to withdraw from research

The right to withdraw from participation in research is recognized in virtually all national and international guidelines for research on human subjects. It is therefore surprising that there has been little justification for that right in the literature. We argue that the right to withdraw should protect research participants from information imbalance, inability to hedge, inherent uncertainty, and untoward bodily invasion, and it serves to bolster public trust in the research enterprise. Although this argument is not radical, it provides a useful way to determine how the right should be applied in various cases.     

A case study of community-based participatory research ethics: The healthy public housing initiative

We conducted and analyzed qualitative interviews with 12 persons working on the Healthy Public Housing Initiative in Boston, Massachusetts in 2001. Our goal was to generate ideas and themes related to the ethics of the community-based participatory research in which they were engaged. Specifically, we wanted to see if we found themes that differed from conventional research that is based on an individualistic ethics. There were clearly distinct ethical issues raised with respect to projects and individuals who engage in community-based collaborations. The differences that arose from the interviews were seeking equality between the partners, the need for the community partner to defend the community, dealing with unflattering data, meeting community expectations and producing tangible benefits to the community. Alison Kole is an MD/MPH candidate, Tufts University School of Medicine.