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Establishing Measures of Clinical Outcomes and Mechanisms of Action of Behavioral Interventions

Behavioral and Social Sciences Research Branch and
Center for Clinical Research
Division of Extramural Research


OBJECTIVE

To establish more robust measures of clinical outcomes, including measures of the mechanisms of behavioral interventions, for studies of oral diseases and conditions. This includes research to determine oral health care outcomes that are valued most by patients with oral diseases and conditions.

BACKGROUND

We lack robust outcome measures for certain oral and craniofacial diseases and conditions. For example, oral mucosal conditions such as pre-malignant oral lesions are currently assessed by lesion size and histology, which may or may not predict malignant transformation. The 2008 Cochrane review of treatments for oral leukoplakia concluded:

“…some researchers used outcomes different from cancer development, in particular various cytological or histological markers or both. Although easier to perform, studies using such outcomes pose a double problem: first there is little evidence of the predictive value of many of those outcomes; second, they are hardly comparable.”

We also lack good measures of the targets of behavioral interventions, and of the mechanisms of action of behavioral interventions. Common targets of behavioral interventions include brushing, flossing, food choices, fluoride use, compliance with use of a study agent, and dental fear. Currently, most behavioral studies assess these important targets via self-report, which is a notoriously poor proxy for actual behavior. Additionally, there are few sound measures of the hypothesized mechanisms of action of health promotion interventions, such as increased motivation, healthy parenting, improved provider-patient communication, and self-efficacy for oral health behaviors. Without strong measures of the outcomes and mechanisms of behavioral interventions, clinical research misses opportunities to progress efficiently and build an integrated science of oral health behavior change.

Finally, there is a need to determine those measures that are best suited to capturing outcomes in therapeutic trials for oral diseases and conditions that are meaningful to patients.

Examples of potential research topics include but are not limited to:

  • incorporating and validating patient-centered outcomes consistent with PCORI, PROMIS, and Neuroscience Blueprint Toolbox research efforts;
  • establishing valid and reliable measures of oral hygiene behaviors that are often the focus of prevention efforts;
  • validating clinical measures of disease outcome for oral diseases, including lesser studied conditions such as endodontic outcomes, clinical outcomes for treatment of children with cleft lip / cleft palate and implant outcomes; and
  • developing better measures of clinical outcomes for orofacial pain and pre-malignant lesions.

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This page last updated: February 26, 2014