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.
[Show abstract][Hide abstract] 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 · 2.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The behavioral clinical trials guidelines presented in this supplement1 were developed to enhance the quality and consistency of research evaluating behav- ioral treatments for primary headache disorders. De- veloped under the auspices of the American Headache Society (AHS), these guidelines are complementary to and modeled after guidelines published by the International Headache Society to address research methodology apropos to drug trials for migraine,2 tension-type headache,3 and cluster headache.4 Ex- plicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials neces- sarily 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 pharmaco- logic research. the behavioral trial guidelines. Emerging from discus- sions and debates that took place during the guideline development, the thesis of each article in the series was judged to be a key methodological issue meriting further articulation and development expressly for headache investigators.5-21 The series is arranged in two sections, with the first examining headache research issues of general relevance7-12 and the sub-
Headache The Journal of Head and Face Pain 06/2005; 45 Suppl 2(s2):S87-9. DOI:10.1111/j.1526-4610.2005.4502001.x · 2.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Theoretical developments and burgeoning research on stress and illness in the mid-20th century yielded the foundations necessary to conceptualize headache as a psychophysiological disorder and eventually to develop and apply contemporary behavioral headache treatments. Over the past three decades, these behavioral headache treatments (relaxation training, biofeedback, cognitive-behavioral therapy, and stress-management training) have amassed a sizeable evidence base. Meta-analytic reviews of the literature consistently have shown behavioral interventions to yield 35% to 55% improvements in migraine and tension-type headache and that these outcomes are significantly superior to control conditions. The strength of the evidence has lead many professional practice organizations to recommend use of behavioral headache treatments alongside pharmacologic treatments for primary headache. The present overview was prepared as a companion article to and intended to provide a background for the Guidelines for Trials of Behavioral Treatments for Recurrent Headache also published within this journal supplement. This article begins with a synopsis of key historical developments leading to our current conceptualization of migraine and tension-type headache as psychophysiological disorders amenable to behavioral intervention. The evolution of the behavioral headache literature is discussed, exemplified by publication trends in the journal Headache. Leading empirically-based behavioral headache interventions are described, and meta-analytic reviews examining the migraine and tension-type headache literatures are summarized, compared, and contrasted. A critique of the methodological quality of the clinical trials literature is presented, highlighting the strengths and weaknesses in relation to recruitment and selection of patients, sample size and statistical power, the use of a credible control, and the reproducibility of the study interventions in clinical practice.
Headache The Journal of Head and Face Pain 06/2005; 45 Suppl 2(S2):S92-109. DOI:10.1111/j.1526-4610.2005.4502003.x · 2.71 Impact Factor
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