Articles:Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs

From unthinkMedia

  • In health care, efficacy trials need to be attempted more often. By not doing so you risk having multiple explanations for issues that arise.
  • The steps need to precede efficacy and effectiveness trials
    1. basic research
    2. hypothesis development, to assure a strong theoretical and empirical basis for innovative programs
    3. pilot applied research
    4. prototype studies
  • more effectiveness trials, to make sure that product works under "real world" conditions. This help standardize implementation and availability.
  • greater attention to matching methodological requirements with phases of research and phases of research with the current state of the art. This can be improved by including comprehensive implementation assessment and process evaluation.
    1. Knowledge of exactly what was delivered
    2. how it was implemented
    3. who it reached (avail- ability)
    4. how the recipients responded to it (acceptance)
    5. range of outcome/impact variables, makes program effectiveness results-or lack of them -much more interpretable and provides leads as to the most efficient means of program dissemination.

glossary terms

  • Acceptance. Attention to, compliance with, or adherence to a treatment or program by the exposed audience. Sometimes assessed by asking subjects to rate their interest in, liking of, enjoyment of, and judgments as to likelihood of success of the program.
  • Availability. Level at which a program is implemented or delivered to the target population, or ease with which the target population can gain access to the pro- gram.
  • Effectiveness. Level of good over harm (or benefits over costs) that a program achieves when received under typical real-world conditions of availability and acceptance.
  • effectiveness trial. Test of the effectiveness of a program under real-world conditions of availability and acceptance. See distinction between treatment and implementation effectiveness below.
  • efficacy. Level of desired effects (good over harm, benefits over costs) of a program when delivered and received under optimum conditions (i.e., when availability and acceptance are maximized).
  • efficacy trial. Test of efficacy. That is, test of level of effects achieved by a program when availability and acceptance are maximized and do not vary significantly.
  • Historical case-control trial. Trial where cases from a previous trial, or archival data, are used as controls.
  • Implementation effectiveness trial. Test of the effectiveness of an efficacious program when implementation can vary, or is deliberately varied, so that both availability and acceptance can vary.
  • Implementation evaluation. Assessment of how, and at what level, a program is implemented, and what and how much were received by the target population; i.e., a type of process evaluation.
  • Program evaluation. Test of the effects of a program as implemented/delivered. Limited in this article to refer to tests of the effects of a program of unknown efficacy, availability, and acceptance.
  • Treatment effectiveness trial. Test of the effectiveness of an efficacious pro- gram under standardized conditions of implementation and, therefore, avail- ability, but where acceptance can vary.

reference

Efficacy and Effectiveness Trials (and Other Phases of Research) in the Development of Health Promotion Programs’ BRIAN R. FLAY, D. PHIL. Health Behavior Reseurch Institute, University of Southern Calijbwia, 35 North Luke A~vnrre, Pasadenu, Calfornia 91 IO1

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