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.

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.

Gut microbiome associations with breast cancer risk factors and tumor characteristics: a pilot study.

OBJECTIVE: To investigate the association between gut microbiome with breast tumor characteristics (receptor status, stage and grade) and known breast cancer risk factors. METHODS: In a pilot cross-sectional study of 37 incident breast cancer patients, fecal samples collected prior to chemotherapy were analyzed by 16S ribosomal RNA (rRNA) gene-based sequencing protocol. Alpha diversity and specific taxa by tumor characteristics and breast cancer risk factors were tested by Wilcoxon rank sum test, and by differential abundance analysis, using a zero-inflated negative binomial regression model with adjustment for total counts, age and race/ethnicity. RESULTS: There were no significant alpha diversity or phyla differences by estrogen/progesterone receptor status, tumor grade, stage, parity and body mass index. However, women with human epidermal growth factor receptor 2 positive (HER2+) (n = 12) compared to HER2- (n = 25) breast cancer showed 12-23% lower alpha diversity [number of species (OTU) p = 0.033, Shannon index p = 0.034], lower abundance of Firmicutes (p = 0.005) and higher abundance of Bacteroidetes (p = 0.089). Early menarche (ages ≤ 11) (n = 11) compared with later menarche (ages ≥ 12) (n = 26) was associated with lower OTU (p = 0.036), Chao1 index (p = 0.020) and lower abundance of Firmicutes (p = 0.048). High total body fat (TBF) (> 46%) (n = 12) compared to lower (≤ 46%) TBF was also associated with lower Chao 1 index (p = 0.011). There were other significant taxa abundance differences by HER2 status, menarche age, as well as other tumor and breast cancer risk factors. CONCLUSIONS AND RELEVANCE: Further studies are needed to identify characteristics of the human microbiome and the interrelationships between breast cancer hormone receptor status and established breast cancer risk factors.

Reducing the Pain Behind Opioid Prescribing in Primary Care.

OBJECTIVE: To describe the efficacy of a comprehensive approach aimed at reducing opioid prescribing in an internal medicine resident clinic. DESIGN: Retrospective observational study. SETTING: Internal medicine primary care resident clinic at a large urban academic medical center. SUBJECTS: All patients receiving opioid prescriptions from the primary care clinic. METHODS: We reviewed pharmacy dispensing data for two hospital-affiliated pharmacies for resident primary care patients filling opioid prescriptions between July 2016 and July 2018. We instituted a comprehensive set of interventions that included resident education, limiting supervision of encounters for long-term opioid therapy (LTOT) to a fixed set of faculty champions, and providing alternate modalities for pain control. We calculated the change in number of opioid prescriptions dispensed, number of patients receiving opioid prescriptions, morphine milligram equivalents (MMEs) dispensed, and average per-patient daily MMEs dispensed. RESULTS: We observed an average monthly reduction of 2.44% (P < 0.001) in the number of prescriptions dispensed and a 1.83% (P < 0.001) monthly reduction in the number of patients receiving prescriptions. Over the two-year period, there was a 74.3% reduction in total MMEs prescribed and a 66.5% reduction in the average MMEs prescribed per patient. CONCLUSIONS: Our findings demonstrate a significant reduction in opioid prescribing after implementation of a comprehensive initiative. Although our study was observational in nature, we witnessed a nearly threefold decrease in opioid prescribing compared with national trends. Our results offer important insights for other primary care resident clinics hoping to engender safe prescribing practices and curb high-dose opioid prescribing.

Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.

BACKGROUND/AIMS: Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients. METHODS: Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features. RESULTS: In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies. CONCLUSIONS: Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.

Re-conceptualizing functional status through experiences of young adults with inflammatory arthritis.

The objective of this study is to assess the impact of inflammatory arthritis on young adults' activity participation using quantitative and qualitative methods to advance the field's conceptualization of functional status. Young adults diagnosed with juvenile idiopathic arthritis or rheumatoid arthritis completed (1) the Health Assessment Questionnaire-Disability Index to determine functional status and (2) the day reconstruction method to explore experiential dimensions of function, including functional performance, functional satisfaction, and severity of arthritis symptoms during activities on the previous day. Bivariate analyses were conducted to examine relationships between functional status, experiential variables, and demographic variables. Open-ended questions were provided for participants to report ways that arthritis affected their participation that were not otherwise reflected within survey questions; responses were numerically coded using summative content analysis. Among 37 participants (24.8 ± 3.3 years old), 70% reported moderate-to-severe disability. On average, participants experienced pain, stiffness, or fatigue for more than 50% of their waking hours. Functional status significantly correlated with functional performance (r = - 0.39, p = 0.02) and satisfaction (r = - 0.39, p = 0.02), yet did not correlate with stiffness or fatigue severity or duration of symptoms throughout the day. Participants described strategies that improved their ability to participate in certain activities but reduced their overall quality of activity engagement and caused emotional distress. Young adults with arthritis may experience more significant functional limitations than previously reported. Traditional measures of functional assessment may not capture experiential components of activity that affect participation, such as severity of stiffness or fatigue or the duration of symptoms throughout the day.

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.

Addressing Diabetes in Primary Care: Hybrid Effectiveness-Implementation Study of Lifestyle Redesign® Occupational Therapy.

IMPORTANCE: Primary health care is rapidly developing as an occupational therapy practice area. Yet, to date, little evidence supports occupational therapy's feasibility and efficacy in primary care settings. OBJECTIVE: To report on the implementation and preliminary clinical outcomes of a Lifestyle Redesign® (LR)-occupational therapy (LR-OT) diabetes management intervention in a primary care clinic. DESIGN: Patients were randomized to be offered LR-OT or to a no-contact comparison group (data not reported). We assessed implementation outcomes using mixed methods. SETTING: Safety-net primary care clinic. PARTICIPANTS: Clinic providers and staff; English- or Spanish-speaking clinic patients ages 18-75 yr with diabetes and a current hemoglobin A1c (HbA1c) ≥ 9.0%. INTERVENTION: Eight 1-hr individual sessions of LR-OT focused on diabetes management. OUTCOMES AND MEASURES: Clinical and health behavior outcomes were assessed via electronic medical record (EMR) review and self-report surveys of patients receiving LR-OT at initial evaluation and discharge. We assessed implementation outcomes (acceptability, appropriateness, feasibility, fidelity, efficiency, and timeliness) using patient and staff surveys, interviews, focus groups, and observations. RESULTS: Seventy-three patients were offered LR-OT: 51 completed one or more sessions, and 38 completed the program. Clinical outcomes among program completers indicate beneficial changes in HbA1c, diabetes self-care, and health status. Implementation challenges included a need for patient and staff education, securing adequate workspace, and establishing a referral process. Factors contributing to implementation success included strong buy-in from clinic leadership, colocation, and shared EMR documentation. CONCLUSIONS AND RELEVANCE: LR-OT is a feasible approach to enhancing service delivery and clinical outcomes in primary care. WHAT THIS ARTICLE ADDS: This study provides insight into factors that may create challenges or contribute to the success of implementing occupational therapy services within primary health care settings. In addition, this study provides preliminary evidence of occupational therapy's effectiveness in improving clinical outcomes among ethnically diverse, low-income patients with diabetes in a safety-net primary care setting.

Supportive care priorities of low-income Latina breast cancer survivors.

PURPOSE: This study investigated the supportive care needs of a sample of low-income Latina breast cancer survivors. METHODS: Ninety-nine Spanish-speaking breast cancer survivors who self-identified as Latina and reported an income below the US Census Bureau low-income threshold were recruited from the oncology clinic of a major public safety net hospital. Eligible participants completed the supportive care needs survey (SCNS-SF34) and a demographic questionnaire. RESULTS: Ninety-three percent of respondents had unmet needs. The majority of frequently reported unmet needs involved (1) access to and delivery of health-related information and (2) physical function. These findings appear to contrast with those of other studies of supportive care needs in heterogeneous cancer survivors, most of which describe psychological concerns as most urgent. CONCLUSIONS: Participants espoused information-related needs with a higher frequency than many other samples of cancer survivors. This study population may also require a particularly high level of assistance with overcoming participation restrictions. Further research is needed to understand these discrepancies and to address unmet needs across all domains.

Metabolic conditions and breast cancer risk among Los Angeles County Filipina Americans compared with Chinese and Japanese Americans.

Accumulating evidence suggests that the aggregation of common metabolic conditions (high blood pressure, diabetes and dyslipidemia) is a risk factor for breast cancer. Breast cancer incidence has risen steadily in Asian American women, and whether these metabolic conditions contribute to breast cancer risk in certain Asian American subgroups is unknown. We investigated the role of physician-diagnosed hypertension, high cholesterol and diabetes separately, and in combination, in relation to the risk of breast cancer in a population-based case-control study of 2,167 Asian Americans diagnosed with breast cancer and 2,035 age and ethnicity matched control women in Los Angeles County. Compared to Asian American women who did not have any of the metabolic conditions, those with 1, 2 or 3 conditions showed a steady increase in risk (respective odds ratios were 1.12, 1.42 and 1.62; P trend = 0.001) with adjustment for covariates including body mass index. Similar significant trends were observed in Filipina Americans (P trend = 0.021), postmenopausal women (P trend =0.001), Asian women who were born in the United States (US) (P trend = 0.052) and migrants who have lived in the US for at least 20 years (P trend = 0.004), but not migrants who lived in the US for <20 years (P trend = 0.64). These results suggest that westernization in lifestyle (diet and physical inactivity) and corresponding increase in adiposity have contributed to the rising prevalence of these metabolic conditions, which in turn, are associated with an increase in breast cancer.

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.

Validation of self-reported comorbidity status of breast cancer patients with medical records: the California Breast Cancer Survivorship Consortium (CBCSC).

PURPOSE: To compare information from self-report and electronic medical records for four common comorbidities (diabetes, hypertension, myocardial infarction, and other heart diseases). METHODS: We pooled data from two multiethnic studies (one case-control and one survivor cohort) enrolling 1,936 women diagnosed with breast cancer, who were members of Kaiser Permanente Northern California. RESULTS: Concordance varied by comorbidity; kappa values ranged from 0.50 for other heart diseases to 0.87 for diabetes. Sensitivities for comorbidities from self-report versus medical record were similar for racial/ethnic minorities and non-Hispanic Whites, and did not vary by age, neighborhood socioeconomic status, or education. Women with a longer history of comorbidity or who took medications for the comorbidity were more likely to report the condition. Hazard ratios for all-cause mortality were not consistently affected by source of comorbidity information; the hazard ratio was lower for diabetes, but higher for the other comorbidities when medical record versus self-report was used. Model fit was better when the medical record versus self-reported data were used. CONCLUSIONS: Comorbidities are increasingly recognized to influence the survival of patients with breast or other cancers. Potential effects of misclassification of comorbidity status should be considered in the interpretation of research results.

Systematic Review of Educational Interventions for Rheumatoid Arthritis.

OBJECTIVE: In this study, we systematically reviewed the effectiveness of educational interventions falling within the scope of occupational therapy practice for people with rheumatoid arthritis (RA). These interventions included disease education, joint protection and energy conservation, psychosocial techniques, pain management, and a combination category. METHOD: Two databases, MEDLINE and CINAHL, and select journals were searched for randomized controlled trials published between January 2002 and June 2015. Qualitative synthesis was used for between-study comparisons. RESULTS: Twenty-two studies, with approximately 2,600 participants, were included. The interventions were found to have strong evidence for constructs that dealt with increasing coping with pain and fatigue as well as maintaining positive affect. There was limited or no evidence supporting the effectiveness of these interventions on most other measured constructs. CONCLUSION: Interventions in which a combination of educational techniques is used may complement pharmacological therapies in the care of people with RA. Future research is needed to identify specific mechanisms of change.

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.

History of Recreational Physical Activity and Survival After Breast Cancer: The California Breast Cancer Survivorship Consortium.

Recent epidemiologic evidence suggests that prediagnosis physical activity is associated with survival in women diagnosed with breast cancer. However, few data exist for racial/ethnic groups other than non-Latina whites. To examine the association between prediagnosis recreational physical activity and mortality by race/ethnicity, we pooled data from the California Breast Cancer Survivorship Consortium for 3 population-based case-control studies of breast cancer patients (n=4,608) diagnosed from 1994 to 2002 and followed up through 2010. Cox proportional hazards models provided estimates of the relative hazard ratio for mortality from all causes, breast cancer, and causes other than breast cancer associated with recent recreational physical activity (i.e., in the 10 years before diagnosis). Among 1,347 ascertained deaths, 826 (61%) were from breast cancer. Compared with women with the lowest level of recent recreational physical activity, those with the highest level had a marginally decreased risk of all-cause mortality (hazard ratio=0.88, 95% confidence interval: 0.76, 1.01) and a statistically significant decreased risk of mortality from causes other than breast cancer (hazard ratio=0.63, 95% confidence interval: 0.49, 0.80), and particularly from cardiovascular disease. No association was observed for breast cancer-specific mortality. These risk patterns did not differ by race/ethnicity (non-Latina white, African American, Latina, and Asian American). Our findings suggest that physical activity is beneficial for overall survival regardless of race/ethnicity.

Intersection of Race/Ethnicity and Socioeconomic Status in Mortality After Breast Cancer.

We investigated social disparities in breast cancer (BC) mortality, leveraging data from the California Breast Cancer Survivorship Consortium. The associations of race/ethnicity, education, and neighborhood SES (nSES) with all-cause and BC-specific mortality were assessed among 9372 women with BC (diagnosed 1993-2007 in California with follow-up through 2010) from four racial/ethnic groups [African American, Asian American, Latina, and non-Latina (NL) White] using Cox proportional hazards models. Compared to NL White women with high-education/high-nSES, higher all-cause mortality was observed among NL White women with high-education/low-nSES [hazard ratio (HR) (95 % confidence interval) 1.24 (1.08-1.43)], and African American women with low-nSES, regardless of education [high education HR 1.24 (1.03-1.49); low-education HR 1.19 (0.99-1.44)]. Latina women with low-education/high-nSES had lower all-cause mortality [HR 0.70 (0.54-0.90)] and non-significant lower mortality was observed for Asian American women, regardless of their education and nSES. Similar patterns were seen for BC-specific mortality. Individual- and neighborhood-level measures of SES interact with race/ethnicity to impact mortality after BC diagnosis. Considering the joint impacts of these social factors may offer insights to understanding inequalities by multiple social determinants of health.

Obesity and mortality after breast cancer by race/ethnicity: The California Breast Cancer Survivorship Consortium.

We investigated body size and survival by race/ethnicity in 11,351 breast cancer patients diagnosed from 1993 to 2007 with follow-up through 2009 by using data from questionnaires and the California Cancer Registry. We calculated hazard ratios and 95% confidence intervals from multivariable Cox proportional hazard model-estimated associations of body size (body mass index (BMI) (weight (kg)/height (m)(2)) and waist-hip ratio (WHR)) with breast cancer-specific and all-cause mortality. Among 2,744 ascertained deaths, 1,445 were related to breast cancer. Being underweight (BMI <18.5) was associated with increased risk of breast cancer mortality compared with being normal weight in non-Latina whites (hazard ratio (HR) = 1.91, 95% confidence interval (CI): 1.14, 3.20), whereas morbid obesity (BMI ≥ 40) was suggestive of increased risk (HR = 1.43, 95% CI: 0.84, 2.43). In Latinas, only the morbidly obese were at high risk of death (HR = 2.26, 95% CI: 1.23, 4.15). No BMI-mortality associations were apparent in African Americans and Asian Americans. High WHR (quartile 4 vs. quartile 1) was associated with breast cancer mortality in Asian Americans (HR = 2.21, 95% CI: 1.21, 4.03; P for trend = 0.01), whereas no associations were found in African Americans, Latinas, or non-Latina whites. For all-cause mortality, even stronger BMI and WHR associations were observed. The impact of obesity and body fat distribution on breast cancer patients' risk of death may vary across racial/ethnic groups.

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.

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.

The California Breast Cancer Survivorship Consortium (CBCSC): prognostic factors associated with racial/ethnic differences in breast cancer survival.

Racial/ethnic disparities in mortality among US breast cancer patients are well documented. Our knowledge of the contribution of lifestyle factors to disease prognosis is based primarily on non-Latina Whites and is limited for Latina, African American, and Asian American women. To address this knowledge gap, the California Breast Cancer Survivorship Consortium (CBCSC) harmonized and pooled interview information (e.g., demographics, family history of breast cancer, parity, smoking, alcohol consumption) from six California-based breast cancer studies and assembled corresponding cancer registry data (clinical characteristics, mortality), resulting in 12,210 patients (6,501 non-Latina Whites, 2,060 African Americans, 2,032 Latinas, 1,505 Asian Americans, 112 other race/ethnicity) diagnosed with primary invasive breast cancer between 1993 and 2007. In total, 3,047 deaths (1,570 breast cancer specific) were observed with a mean (SD) follow-up of 8.3 (3.5) years. Cox proportional hazards regression models were fit to data to estimate hazards ratios (HRs) and 95 % confidence intervals (CIs) for overall and breast cancer-specific mortality. Compared with non-Latina Whites, the HR of breast cancer-specific mortality was 1.13 (95 % CI 0.97-1.33) for African Americans, 0.84 (95 % CI 0.70-1.00) for Latinas, and 0.60 (95 % CI 0.37-0.97) for Asian Americans after adjustment for age, tumor characteristics, and select lifestyle factors. The CBCSC represents a large and racially/ethnically diverse cohort of breast cancer patients from California. This cohort will enable analyses to jointly consider a variety of clinical, lifestyle, and contextual factors in attempting to explain the long-standing disparities in breast cancer outcomes.