Behavioral headache research: methodologic considerations and research design alternatives.
ABSTRACT Behavioral headache treatments have garnered solid empirical support in recent years, but there is substantial opportunity to strengthen the next generation of studies with improved methods and consistency across studies. Recently, Guidelines for Trials of Behavioral Treatments for Recurrent Headache were published to facilitate the production of high-quality research. The present article compliments the guidelines with a discussion of methodologic and research design considerations. Since there is no research design that is applicable in every situation, selecting an appropriate research design is fundamental to producing meaningful results. Investigators in behavioral headache and other areas of research consider the developmental phase of the research, the principle objectives of the project, and the sources of error or alternative interpretations in selecting a design. Phases of clinical trials typically include pilot studies, efficacy studies, and effectiveness studies. These trials may be categorized as primarily pragmatic or explanatory. The most appropriate research designs for these different phases and different objectives vary on such characteristics as sample size and assignment to condition, types of control conditions, periods or frequency of measurement, and the dimensions along which comparisons are made. A research design also must fit within constraints on available resources. There are a large number of potential research designs that can be used and considering these characteristics allows selection of appropriate research designs.
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ABSTRACT: Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.Headache The Journal of Head and Face Pain 04/2005; 45(s2):S110 - S132. DOI:10.1111/j.1526-4610.2005.4502004.x · 3.19 Impact Factor
- Headache The Journal of Head and Face Pain 06/2005; 45(5):408-10. DOI:10.1111/j.1526-4610.2005.05090.x · 3.19 Impact Factor
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ABSTRACT: The present article reviews the concept of statistical power analysis for research designs in headache. First, we present a basic overview of the concepts of statistical hypothesis testing. Then we discuss the elements of power analysis and, where appropriate, we address conventions for power calculations. We offer, for public use, an applied power calculator for two applications that are often encountered in headache research. We intend to help headache researchers design trials with adequate statistical power by offering a conceptual overview and the power calculators. In closing, we briefly address the implications of the present trend toward reporting point estimates of effect sizes with confidence levels.Headache The Journal of Head and Face Pain 06/2005; 45(5):414-8. DOI:10.1111/j.1526-4610.2005.05092.x · 3.19 Impact Factor