Assessment of pediatric shoulder range of motion and loading response to evaluate the biofidelity of the Large Omni-directional Child (LODC) anthropomorphic test device (ATD) shoulder design.

The shoulder girdle complex, through engagement with the seat belt, influences motor vehicle occupant upper body movement during frontal impacts, affecting the movement of the head and spine. The recently developed Large Omni-directional Child (LODC) anthropomorphic test device (ATD) was designed with flexible shoulder girdle structures that capture the unique kinematics in pediatric occupants. However, the LODC shoulder has not been evaluated for biofidelity due to the lack of biomechanical data available on pediatric shoulder responses. This study evaluated quasi-static pediatric shoulder girdle complex responses through non-invasive displacement measurements. These data were obtained to evaluate, and, if necessary, improve the biofidelity of the LODC ATD. Shoulder range of motion and anthropometric measurements were obtained from 25 pediatric volunteers, ages 8-12 years old. Loads were applied bilaterally exclusively to the shoulder complexes in increments of 25 N up to 150 N per shoulder at 90 and 135 degrees of shoulder flexion. Still photos were used to determine shoulder displacement in the sagittal plane from images captured prior to and following the load applications. Data analysis consisted of motion tracking to evaluate the absolute and relative displacement of the right acromion and T1. The displacements for each volunteer were normalized based on the volunteer's shoulder width compared to the shoulder width of the LODC ATD. For the 90° load, the acromion moved relative to T1 an average of 28.1 mm forward and 3.1 mm downward at maximum displacement. For the 135° load, the acromion moved relative to T1 an average of 15.5 mm forward and 42.7 mm upward at maximum displacement. Similar displacements at higher loads indicated that the volunteers achieved their maximum range of motion. The results of this study will be compared to the LODC ATD, assessing the biofidelity of the shoulder complex.

Pressure Injury Data Reconciliation in a Randomized Controlled Trial.

OBJECTIVE: To advance pressure injury (PrI) research in individuals with spinal cord injury (SCI) by describing lessons learned and recommendations for future research, ultimately promoting PrI prevention and more effective wound care. This paper describes the detailed procedures undertaken to collect and reconcile PrI data and summarizes the types of discrepancies identified. DESIGN: Secondary analyses of PrI data collected between 2009 and 2014 in a randomized controlled trial (parent study). SETTING: Participants in the parent study were recruited from a large rehabilitation center in the Los Angeles area that serves primarily individuals with limited resources. PARTICIPANTS: 232 participants with SCI and a history of 1 or more medically serious PrI (MSPrI) in the previous 5 years. INTERVENTIONS: Participants in the parent study were randomized to a 12-month PrI prevention intervention led by an occupational therapist, or to usual care. MAIN OUTCOME MEASURES: Relations among PrI characteristics, data sources (phone interviews, skin checks, paper and electronic medical records [MRs]), and treatment condition, and sensitivity of 6 different data sources in detecting MSPrIs. RESULTS: The majority (62%) of MSPrIs were in the pelvic region. MRs detected 82% of the MSPrIs overall, making it the most sensitive data source, and scheduled skin checks were the second-most sensitive data source, finding 37% of the MSPrIs. CONCLUSIONS: MR review is the preferred method for ascertaining MSPrIs in clinical trials of interventions designed to reduce the incidence of these injuries. When multiple sources of information are used, careful reconciliation of reports is necessary to ensure accuracy.

Optimizing Occupations, Habits, and Routines for Health and Well-Being With Lifestyle Redesign®: A Synthesis and Scoping Review.

IMPORTANCE: Lifestyle Redesign® originated as a preventive occupational therapy intervention for healthy older adults, and it was found to be both effective and cost effective in the Well Elderly Studies initiated in the 1990s. Building on that empirical foundation, the scope of Lifestyle Redesign has been greatly expanded as a general intervention framework addressing prevention and chronic condition management in a wide range of populations, settings, and conditions. Yet until now, its full scope, defining characteristics, and supporting evidence have not been clearly and succinctly described, limiting its potential reach and impact. OBJECTIVE: To outline the definition and key characteristics of Lifestyle Redesign, provide a scoping review of its evidence base and future directions for research, describe its current applications, and make recommendations for its use in clinical practice. EVIDENCE REVIEW: We searched PubMed and CINAHL, tables of contents of 10 occupational therapy journals, and citations in two seminal Lifestyle Redesign publications to identify articles published in 1997-2020 that described quantitative outcomes (for n ≥ 20) of interventions meeting the defining characteristics of Lifestyle Redesign. FINDINGS: Our scoping review yielded 12 publications providing supportive evidence for Lifestyle Redesign's positive impact on a range of health and well-being outcomes among both well populations and those with chronic conditions. CONCLUSIONS AND RELEVANCE: Lifestyle Redesign has the potential to meet a growing need in clinical and community settings for health care services that address prevention, health promotion, and chronic disease management. What This Article Adds: Current evidence supports the use of Lifestyle Redesign to improve health and well-being for a range of client populations. This review outlines its defining characteristics and current applications to improve its implementation in clinical practice and expand related research efforts.

Long-Term Follow-Up of a Lifestyle Intervention for Late-Midlife, Rural-Dwelling Latinos in Primary Care.

IMPORTANCE: Rural-dwelling Latinos are an underresourced population in need of accessible and effective wellness programs. OBJECTIVE: To evaluate patients' long-term health-related outcomes after lifestyle intervention. DESIGN: An uncontrolled pilot trial assessing change in health from pretreatment to long-term follow-up (12 mo after intervention completion, no contact) and from posttreatment to long-term follow-up. SETTING: Rural, community-based primary care. PARTICIPANTS: Latino and Hispanic safety-net primary care patients, ages 50 to 64 yr. INTERVENTION: A culturally tailored, 4-mo lifestyle intervention co-led by occupational therapy practitioners and Latino community health workers that features telehealth and in-home sessions covering topics such as healthy eating and navigating health care. OUTCOMES AND MEASURES: Self-reported and physiological outcomes: symptom-well-being (primary), stress, sleep disturbance, social satisfaction, physical activity, patient activation, blood pressure, and weight. Exit interviews addressed health experiences and intervention impact on participants' lives. RESULTS: Participants (N = 27) demonstrated clinically significant pretreatment to long-term follow-up benefits in all symptom-well-being dimensions (Cohen's d ≥ 0.8, p ≤ .004), with additional gains from posttreatment to long-term follow-up (d ≥ 0.4, p ≤ .05). Significant improvements from pre- to posttreatment in systolic blood pressure, stress, and social role and activity satisfaction were maintained at long-term follow-up. No changes were observed in weight, physical activity, or diastolic blood pressure. Participants described the intervention's sustained positive effect on their wellness. CONCLUSIONS AND RELEVANCE: A lifestyle intervention led by occupational therapy practitioners and community health workers in a primary care context has potential to achieve long-term health benefits in rural-dwelling, late-midlife Latinos. WHAT THIS ARTICLE ADDS: This study reveals that rural, late-midlife Latinos showed long-lasting improvements in psychological and physical health after finishing a program that helped them make healthy lifestyle choices. This finding supports the unique contribution of occupational therapy in primary care settings.

A qualitative analysis of pressure injury development among medically underserved adults with spinal cord injury.

Purpose: Medically underserved adults with spinal cord injury (SCI) remain at high risk of incurring medically serious pressure injuries even after receiving education in prevention techniques. The purpose of this research is to identify circumstances leading to medically serious pressure injury development in medically underserved adults with SCI during a lifestyle-based pressure injury prevention program, and provide recommendations for future rehabilitation approaches and intervention design.Methods: This study entailed a qualitative secondary case analysis of treatment notes from a randomized controlled trial. Participants were 25 community-dwelling, medically underserved adults with SCI who developed medically serious pressure injuries during the course of the intervention of the RCT.Results and conclusions: Among the 25 participants, 40 unique medically serious pressure injuries were detected. The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach. Together, these factors may have undermined the effectiveness of the intervention program. Modifications, such as assessing health literacy levels of patients prior to providing care, providing tailored wound care education, and focusing on equipment needs, have potential for altering future rehabilitation programs and improving health outcomes.Implications for rehabilitationTo provide patients with spinal cord injury with the necessary information to prevent medically serious pressure injury development, health care providers need to understand their patient's unique personal contexts, including socio-economic status, language skills, and mental/cognitive functioning.When providing wound care information to patients with spinal cord injury who have developed a medically serious pressure injury, practitioners should take into account the level of health literacy of their patient in order to provide education that is appropriate and understandable.Practitioners should be aware of how to help their patient advocate for outside services and care that address their equipment needs, such as finding funding or grants to pay for expensive medical equipment.

Auditory event-related potentials and associations with sensory patterns in children with autism spectrum disorder, developmental delay, and typical development.

Atypical sensory response patterns are common in children with autism and developmental delay. Expanding on previous work, this observational electroencephalogram study assessed auditory event-related potentials and their associations with clinically evaluated sensory response patterns in children with autism spectrum disorder (n = 28), developmental delay (n = 17), and typical development (n = 39). Attention-orienting P3a responses were attenuated in autism spectrum disorder relative to both developmental delay and typical development, but early sensory N2 responses were attenuated in both autism spectrum disorder and developmental delay relative to typical development. Attenuated event-related potentials involving N2 or P3a components, or a P1 × N2 interaction, were related to more severe hyporesponsive or sensory-seeking response patterns across children with autism spectrum disorder and developmental delay. Thus, although attentional disruptions may be unique to autism spectrum disorder, sensory disruptions appear across developmental delay and are associated with atypical sensory behaviors.

Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study.

CONTEXT/OBJECTIVE: Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. DESIGN: A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. SETTING: Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. PARTICIPANTS: Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. INTERVENTIONS: The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. OUTCOME MEASURES: Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. RESULTS: Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants. CONCLUSIONS: Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. TRIAL REGISTRATION: ClinicalTrials.gov NCT01999816.

A Pilot Study of the ¡Vivir Mi Vida! Lifestyle Intervention for Rural-Dwelling, Late-Midlife Latinos: Study Design and Protocol.

Older, rural-dwelling Latinos face multiple health disparities. We describe the protocol of a pilot study of a community health worker-occupational therapist-led lifestyle program, ¡Vivir Mi Vida! ( ¡VMV!), designed for delivery in primary care and adapted for late-midlife, Latino rural-living patients. Using mixed methods, we collected feasibility, acceptability, and preliminary efficacy data on ¡VMV!. Forty 50- to 64-year-old Latinos participated in a 16-week lifestyle intervention led by a community health worker-occupational therapist team. We conducted pre- and post-intervention assessments to evaluate the efficacy of ¡VMV! in improving psychosocial and clinical health outcomes. Focus groups and interviews were held post-intervention with participants and key stakeholders to assess feasibility and acceptability. This is the first trial designed to evaluate a lifestyle intervention that includes collaboration between occupational therapists and community health workers within primary care. The detailed description of methodology promotes research transparency and reproducibility of a community health worker-occupational therapist-led lifestyle intervention.

Contextualizing the Positive Effects of the Well Elderly 2 Trial: A Response to Schelly and Ohl (2019).

IMPORTANCE: A recent reanalysis of data from the Well Elderly (WE) 2 study purportedly indicated that the intervention did not achieve clinically meaningful or statistically significant effects; this article addresses these criticisms. OBJECTIVE: To contextualize the WE 2 study as targeting a nonclinical population and demonstrate that the intervention produced substantively important, statistically significant effects. DESIGN: Secondary analysis of WE 2 intervention-based pre-post change scores. SETTING: The original trial occurred primarily in senior centers and senior housing facilities in greater Los Angeles. PARTICIPANTS: Independent-living older adults (N = 324) who were assessed before and after intervention. INTERVENTION: The WE intervention, a version of the Lifestyle Redesign® (LR) approach, was administered by occupational therapists over 6 mo by means of group and individual sessions. OUTCOMES AND MEASURES: The 36-item Short Form Health Survey, the Life Satisfaction Index-Z, and the Center for Epidemiologic Studies Depression Scale. RESULTS: The WE intervention was associated with statistically significant improvement on 10 of 12 outcome variables that were examined. CONCLUSIONS AND RELEVANCE: Because the WE intervention was hypothesized to reduce age-related decline and followed a population-oriented approach, the expectation that average results would be clinically meaningful was inappropriate. The intervention produced positive effects across a wide array of outcome domains. In settings in which clinical meaningfulness is an appropriate index of intervention outcomes, evidence suggests that LR produces effects that are clinically meaningful. As an evidence-based intervention, LR should be considered useful both in population-oriented contexts and in addressing discrete health conditions. WHAT THIS ARTICLE ADDS: Valid analyses demonstrate that the positive experimental effects of the WE 2 study are, in fact, genuine and cost-effective, and LR in clinically oriented contexts has produced statistically significant, clinically meaningful results. Clearly and accurately representing the evidence base of occupational therapy in prevention and chronic care is of critical importance to advance the field as a whole.

Longitudinal assessment of stability of sensory features in children with autism spectrum disorder or other developmental disabilities.

Prior research on the stability of sensory processing problems in children with autism spectrum disorder (ASD) or other developmental disabilities (DD) has produced inconsistent results. We employed a longitudinal study design to assess the stability of three clinical sensory response patterns: hyporesponsiveness; hyperresponsiveness; and sensory interests, repetitions, and seeking behaviors (SIRS). Parents of children with ASD (n = 55) or DD (n = 35) responded to sensory questionnaires at two time points (T1 and T2) separated by 3.3 years on average, with the children aged 2-12 years (M = 5.69 ± 2.46) at the first assessment. For each sensory response pattern, regression analysis revealed that, for both ASD and DD groups, scores at T1 were strong predictors of scores at T2. Over the longitudinal assessment interval, there was a significant mean decline in severity for SIRS in both groups and for hyporesponsiveness in the ASD group. Parental estimates of the amount of therapy services received were positively associated with the severity of sensory features at T2, an outcome that may result from increased intervention dosages being administered to children who fail to improve over time. The results are discussed in terms of person-centered and environmental considerations, which, in combination, have the capacity to affect stability outcomes for sensory features. Autism Research 2019, 12: 100-111. © 2018 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Children with autism spectrum disorder (ASD) and other developmental disabilities (DD) may process sensory information differently from those who do not have ASD. For example, some children may be over-responsive or under-responsive to sound or touch. In this study, we showed that sensory features in preschool/school-aged children with ASD and DD tend to decrease on average over a several year period. However, individual children tend to retain their ranking (low or high in sensory features) in comparison to other children over time.

Evaluation of ¡Vivir Mi Vida! to improve health and wellness of rural-dwelling, late middle-aged Latino adults: results of a feasibility and pilot study of a lifestyle intervention.

AimThe aim of this study was to determine the feasibility and efficacy of a culturally tailored lifestyle intervention, ¡Vivir Mi Vida! (Live My Life!). This intervention was designed to improve the health and well-being of high risk late middle-aged Latino adults and to be implemented in a rural primary care system. BACKGROUND: Rural-dwelling Latino adults experience higher rates of chronic disease compared with their urban counterparts, a disparity exacerbated by limited access to healthcare services. Very few lifestyle interventions exist that are both culturally sensitive and compatible for delivery within a non-metropolitan primary care context. METHODS: Participants were 37 Latino, Spanish-speaking adults aged 50-64-years-old, recruited from a rural health clinic in the Antelope Valley of California. ¡Vivir Mi Vida! was delivered by a community health worker-occupational therapy team over a 16-week period. Subjective health, lifestyle factors, and cardiometabolic measures were collected pre- and post-intervention. Follow-up interviews and focus groups were held to collect information related to the subjective experiences of key stakeholders and participants.FindingsParticipants demonstrated improvements in systolic blood pressure, sodium and saturated fat intake, and numerous patient-centered outcomes ranging from increased well-being to reduced stress. Although participants were extremely satisfied with the program, stakeholders identified a number of implementation challenges. The findings suggest that a tailored lifestyle intervention led by community health workers and occupational therapists is feasible to implement in a primary care setting and can improve health outcomes in rural-dwelling, late middle-aged Latinos.

Understanding the Mechanisms of Change in a Lifestyle Intervention for Older Adults.

Purpose of the Study: This study investigated the mechanisms of change underlying an activity-based lifestyle intervention, an occupational therapy program aimed at promoting healthy habits, and routines in older adults. We examined two activity-relevant factors as potential mediators linking the intervention to reduced symptoms of depression: activity frequency and global perceptions of activity significance. Social connections and perceived control were assessed to understand how activity-related factors relate to reduced symptoms of depression. Design and Methods: The sample consisted of 460 multiethnic community-dwelling older adults aged 60-95 years. Participants were randomly assigned to a 6-month lifestyle redesign intervention (n = 232) or a no-treatment control (n = 228) condition. After the 6-month period, 360 individuals completed post-testing. Latent change score models were used to represent changes from baseline over the experimental interval. Structural equation models were applied to examine the indirect effects of the intervention on reduced depressive symptoms. Results: The results demonstrated significant indirect effects from intervention receipt to decreased depressive symptoms via increased activity frequency and activity significance. Higher activity frequency was linked to fewer depressive symptoms via heightened social connections, whereas increased activity significance was associated with fewer depressive symptoms via enhanced perceived control. Implications: The results support basic principles of occupational therapy by highlighting important mediating roles of activity frequency and activity significance in reducing depressive symptoms. Understanding of these change mechanisms can help optimize activity-centered interventions to reduce depressive symptoms.

Deciphering participation: an interpretive synthesis of its meaning and application in rehabilitation.

PURPOSE: Participation is widely recognized as an important outcome for rehabilitation. However, it lacks a universally accepted definition. The purpose of this review is to synthesize the literature about participation in rehabilitation in order to clarify the term and increase its usefulness for rehabilitation providers and researchers. METHODS: We undertook an interpretive synthesis of the literature, drawing from a broad and varied selection of the vast number of publications on the subject of participation. The search and analysis was iterative and continued until saturation of themes was achieved. RESULTS AND CONCLUSIONS: Seventy-six articles were included in our analysis. We argue that three essential dimensions - performance, subjective experience, and interpersonal connection - constitute participation. We further divide participation into community-based and interventional contexts. Interventional participation is circumscribed by the treatment setting, whereas community-based encompasses all other areas. Participation in either interventional or community-based contexts is largely determined by the available opportunities from which a person can choose, with such opportunities affected by conditions that are either internal or external to the individual. As defined in this framework, participation is not inherently good or bad; rather, its effect is determined by a person's unique life circumstances and the impact may not always be apparent. We posit this model as a resource for future research as well as clinical reasoning. Implications for Rehabilitation The often tacit assumption that increasing participation is a desirable outcome needs to be challenged and considered in each patient's life situation. Treatment settings constitute a unique context in which patients participate. Intervention goals should be clearly connected with patients' personal goals for community-based participation.

Systematic review of behavioral and educational interventions to prevent pressure ulcers in adults with spinal cord injury.

OBJECTIVE: To investigate the efficacy of behavioral or educational interventions in preventing pressure ulcers in community-dwelling adults with spinal cord injury (SCI). DATA SOURCES: Cochrane, Clinical Trials, PubMed, and Web of Science were searched in June 2016. The search combined related terms for pressure ulcers, spinal cord injury, and behavioral intervention. Each database was searched from its inception with no restrictions on year of publication. REVIEW METHODS: Inclusion criteria required that articles were (a) published in a peer-reviewed journal in English, (b) evaluated a behavioral or educational intervention for pressure ulcer prevention, (c) included community-dwelling adult participants aged 18 years and older with SCI, (d) measured pressure ulcer occurrence, recurrence, or skin breakdown as an outcome, and (e) had a minimum of 10 participants. All study designs were considered. Two reviewers independently screened titles and abstracts. Extracted information included study design, sample size, description of the intervention and control condition, pressure ulcer outcome measures, and corresponding results. RESULTS: The search strategy yielded 444 unique articles of which five met inclusion criteria. Three were randomized trials and two were quasi-experimental designs. A total of 513 participants were represented. The method of pressure ulcer or skin breakdown measurement varied widely among studies. Results on pressure ulcer outcomes were null in all studies. Considerable methodological problems with recruitment, intervention fidelity, and participant adherence were reported. CONCLUSIONS: At present, there is no positive evidence to support the efficacy of behavioral or educational interventions in preventing pressure ulcer occurrence in adults with SCI.

Napping and Nighttime Sleep: Findings From an Occupation-Based Intervention.

OBJECTIVE: To describe sleeping behaviors and trends over time among an ethnically diverse group of community-living older adults. METHOD: A descriptive secondary data analysis of a subsample (n = 217) from the Lifestyle Redesign randomized controlled trial was done to explore baseline napping and sleeping patterns as well as 6-mo changes in these outcomes. RESULTS: At baseline, the average time sleeping was 8.2 hr daily (standard deviation = 1.7). Among all participants, 29% reported daytime napping at baseline, of which 36% no longer napped at follow-up. Among participants who stopped napping, those who received an occupation-based intervention (n = 98) replaced napping time with nighttime sleep, and those not receiving an intervention (n = 119) experienced a net loss of total sleep (p < .05). CONCLUSION: Among participants who stopped napping, the occupation-based intervention may be related to enhanced sleep. More research examining the role of occupation-based interventions in improving sleep is warranted.

Developing Occupation-Based Preventive Programs for Late-Middle-Aged Latino Patients in Safety-Net Health Systems.

Latino adults between ages 50 and 60 yr are at high risk for developing chronic conditions that can lead to early disability. We conducted a qualitative pilot study with 11 Latinos in this demographic group to develop a foundational schema for the design of health promotion programs that could be implemented by occupational therapy practitioners in primary care settings for this population. One-on-one interviews addressing routines and activities, health management, and health care utilization were conducted, audiotaped, and transcribed. Results of a content analysis of the qualitative data revealed the following six domains of most concern: Weight Management; Disease Management; Mental Health and Well-Being; Personal Finances; Family, Friends, and Community; and Stress Management. A typology of perceived health-actualizing strategies was derived for each domain. This schema can be used by occupational therapy practitioners to inform the development of health-promotion lifestyle interventions designed specifically for late-middle-aged Latinos.

Development and validation of the activity significance personal evaluation (ASPEn) scale.

BACKGROUND/AIM: Engagement in desired occupations can promote health and wellbeing in older adults. Assessments of engagement often measure frequency, amount or importance of specific activities. This study aimed to develop a scale to measure older adults' evaluation of the extent to which their everyday activities are contributing to their health and wellness. METHODS: Eighteen items, each scored with a seven-point rating scale, were initially developed by content experts, covering perceptions of how daily activities contribute to physical and mental health, as well as satisfaction and activity participation in the last six months. Rasch analysis methods were used to refine the scale using the pencil and paper responses of 460 community-living older adults. RESULTS: Initial Rasch analysis indicated three unlabelled rating scale categories were seldom used, reducing measurement precision. Five items were conceptually different by misfit statistics and principal component analysis. Subsequently, those items were removed and the number of rating scale steps reduced to 4. The remaining 13-item, 4-step scale, termed the Activity Significance Personal Evaluation (ASPEn), formed a unidimensional hierarchy with good fit statistics and targeting. Person separation reliability (2.7) and internal consistency (.91) indicated the tool is appropriate for individual person measurement. Relative validity indicated equivalence between Rasch measures and total raw scores. CONCLUSIONS: ASPEn is a brief, easily administered assessment of older adults' perception of the contribution of everyday activities to personal health and wellness. ASPEn may facilitate occupational therapy practice by enabling clinicians to assess change in meaning of an older adult's activity over time.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

BACKGROUND: Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. PURPOSE: We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. METHODS: Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. RESULTS: PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. LIMITATIONS: We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. CONCLUSIONS: Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Predictors of retention among African American and Hispanic older adult research participants in the Well Elderly 2 randomized controlled trial.

The purpose of this study was to document predictors of long-term retention among minority participants in the Well Elderly 2 Study, a randomized controlled trial of a lifestyle intervention for community-dwelling older adults. The primary sample included 149 African American and 92 Hispanic men and women aged 60 to 95 years, recruited at senior activity centers and senior residences. Chi-square and logistic regression procedures were undertaken to examine study-based, psychosocial and health-related predictors of retention at 18 months following study entry. For both African Americans and Hispanics, intervention adherence was the strongest predictor. Retention was also related to high active coping and average (vs. high or low) levels of activity participation among African Americans and high social network strength among Hispanics. The results suggest that improved knowledge of the predictors of retention among minority elders can spawn new retention strategies that can be applied at individual, subgroup, and sample-wide levels.

Avoid lost discoveries, because of violations of standard assumptions, by using modern robust statistical methods.

OBJECTIVES: Recently, there have been major advances in statistical techniques for assessing central tendency and measures of association. The practical utility of modern methods has been documented extensively in the statistics literature, but they remain underused and relatively unknown in clinical trials. Our objective was to address this issue. STUDY DESIGN AND PURPOSE: The first purpose was to review common problems associated with standard methodologies (low power, lack of control over type I errors, and incorrect assessments of the strength of the association). The second purpose was to summarize some modern methods that can be used to circumvent such problems. The third purpose was to illustrate the practical utility of modern robust methods using data from the Well Elderly 2 randomized controlled trial. RESULTS: In multiple instances, robust methods uncovered differences among groups and associations among variables that were not detected by classic techniques. In particular, the results demonstrated that details of the nature and strength of the association were sometimes overlooked when using ordinary least squares regression and Pearson correlation. CONCLUSION: Modern robust methods can make a practical difference in detecting and describing differences between groups and associations between variables. Such procedures should be applied more frequently when analyzing trial-based data.