
Editorial
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Occupational therapy leaders have emphasized the importance of intervention effectiveness research. The CONSORT and TREND checklists have been suggested as useful tools for reporting the results of randomized and nonrandomized studies, respectively. Despite such recommendations, research protocols and reports continue to underutilize the available tools, a situation reflecting limited resources for and experience with the conduct of effectiveness research. To address this issue, and using the CONSORT statement to structure the analysis, this article discusses strategies for optimization of protocol development, treatment fidelity, adherence to treatment, and quality control. We recommend several approaches to increase the quality of research throughout these various processes. Examples of implementation from our laboratory provide evidence of the utility of these strategies.
The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these barriers. The use of active controls, technology-supported visit reminders, and up-front scheduling is recommended to prevent attrition and maximize retention of participants.
Selecting an appropriate outcome measure is a critical step in designing valid and useful clinical trials and outcome studies. This selection process needs to extend beyond examining basic psychometric properties to consider additional features of instruments that may affect their validity and utility for the study’s purpose. This article discusses these additional factors and their potential impact on outcome measurement. Guidelines are proposed to help clinical researchers and consumers of clinical research literature evaluate the match between the study purpose, population, and instrument.
Many factors can affect the successful implementation and validity of intervention studies. A primary purpose of feasibility and pilot studies is to assess the potential for successful implementation of the proposed main intervention studies and to reduce threats to the validity of these studies. This article describes a typology to guide the aims of feasibility and pilot studies designed to support the development of randomized controlled trials and provides an example of the studies underlying the development of one rehabilitation trial. The purpose of most feasibility and pilot studies should be to describe information and evidence related to the successful implementation and validity of a planned main trial. Null hypothesis significance testing is not appropriate for these studies unless the sample size is properly powered. The primary tests of the intervention effectiveness hypotheses should occur in the main study, not in the studies that are serving as feasibility or pilot studies.
This article examines the challenges in and progress of behavioral intervention research, the trajectory followed for introducing new interventions, and key considerations in protocol development. Developing and testing health-related behavioral interventions involve an incremental and iterative process to build a robust body of evidence that initially supports feasibility and safety, then proves efficacy and effectiveness, and subsequently involves translation, implementation, and sustainability in a real-world context. This process occurs over close to two decades and yields less than 14% of the evidence being integrated into practice. New hybrid models that blend test phases and involve stakeholders and end users up front in developing and testing interventions may shorten this time frame and enhance adoption of a proven intervention. Knowledge of setting exigencies and implementation challenges may also inform intervention protocol development and facilitate rapid and efficient translation into practice. Although interventions needed to improve the public’s health are complex and funding lags behind, introducing new interventions remains a critical and most worthy pursuit.
Despite the availability of innovative health care research, a gap exists between research-generated knowledge and the utilization of that knowledge in real-world practice settings. This article examines the transition from research to implementation in the context of the dissemination of A. Jean Ayres’ sensory integration procedures and of the challenges currently facing the University of Southern California Well Elderly Studies research team. Drawing from the emerging field of implementation science, this article discusses how researchers can develop an implementation plan to more easily translate evidence into practice. Such plans should address the intervention’s reach (i.e., its capacity to penetrate into the intended target population), the settings for which it is applicable, the leaders who will encourage practitioner uptake, stakeholder groups, and challenges to dissemination. By taking action to ensure the more effective dissemination of research-generated knowledge, researchers can increase the likelihood that their interventions will lead to improvements in practice and more effective care for consumers.
The psychometric properties of assessments must be established for specific populations. The psychometric properties of the Children’s Assessment of Participation and Enjoyment/Preference for Activities of Children have been studied only in a sample of children with physical disability. We conducted a study to determine the appropriateness of drawing inferences from this assessment for children with high-functioning autism (HFA). The content validity and test–retest reliability (
OBJECTIVE: The goal of this study was to determine whether pediatric occupational therapy practitioners implemented family-centered principles in their practice.
METHOD: Twenty-eight occupational therapy practitioners were interviewed in three practice settings: home based, clinic based, and school based. A grounded theory approach was used to analyze the results. Responses were compared across respondents and across practice settings.
RESULTS: Responses varied among practitioners and, more significantly, practice settings. A continuum of family-centered practice was demonstrated, with home-based practice as the most family centered, school-based practice as the least family centered, and clinic practice varying in between.
CONCLUSION: Occupational therapy practitioners are familiar with most principles of family-centered practice. However, implementation of those principles differs significantly across practice settings.
The Practical Skills Test (PST) is a new assessment of individuals’ knowledge of life skills. We evaluated the PST’s reliability, validity, and sensitivity to change among a homeless population. Participants were 123 homeless persons in a longitudinal experimental study who were assessed before and after intervention with the PST, Allen Cognitive Level Screen–2000 (ACLS–2000), and Impact of Event Scale–Revised (IES–R). The PST showed generally good internal consistency, no floor effects, and limited ceiling effects (<20% on each test). Supportive evidence for the PST’s convergent validity was seen in its moderate correlations with the ACLS–2000; we found no significant correlation with the IES–R. Paired

Historical inquiry enriches occupational therapy practice by identifying enduring values and inspiring future excellence. This study presents for the first time the pioneering life and work of Philip King Brown, a San Francisco physician who used occupation to treat the physical, mental, and social effects of tuberculosis (TB) at Arequipa Sanatorium, the institution he founded in 1911. Through textual analysis of the Arequipa Sanatorium Records, this article evaluates and defends Brown’s assertion that his institution was medically and socially experimental. The Arequipa Sanatorium promoted occupational therapy by demonstrating its viability in the treatment of TB, the era’s most critical health threat. It also put into practice the ideals of holism, humanism, and occupational justice that resonate within the profession today. Finally, Arequipa provided an example of how an occupation program can change the public perception of disability.
Many occupational therapy practitioners consider evidence-based practice (EBP) to be the means by which occupational therapy can prove the validity of its services and thus support the legitimacy of our profession. The unquestioned acceptance of EBP as the way to establish credibility concerns me; unchallenged acceptance of any idea concerns me. Do practitioners accept EBP as the paradigm for guiding occupational therapy practice and research solely because it is presented as what we must do? I believe that practitioners must examine the implications for our profession of accepting EBP without question. In this article, I review EBP, present criticisms and concerns voiced by other professions and, finally, examine the implications of adopting an EBP perspective that replaces theory-directed practice.