Cheryl Vigen PhD
Associate Professor of Research
Room: CHP 101J
Cheryl Vigen is an Associate Professor of Research in the USC Division of Occupational Science and Occupational Therapy, and a member of the SC CTSI Biostatistics, Epidemiology, and Research Design (BERD) Core in the USC Division of Biostatistics and Epidemiology. With advanced degrees in epidemiology, biostatistics and mathematics she has served as biostatistician on several clinical trials and has experience in a wide variety of projects involving epidemiology, statistics, and data management. These projects have covered medical areas as diverse as cancer, HIV, cardiovascular disease, ophthalmology, dentistry, and hepatology. In addition to managing and analyzing data, she works closely with OSOT study teams to monitor and assess the progress of the studies and to trouble-shoot problems and concerns. She has been particularly involved in the Resilient, Empowered, Active Living (REAL) with Diabetes Study, the Pressure Ulcer Prevention Study (PUPS), and the Well Elderly Study, all major clinical trials conducted by USC Chan OSOT. Dr. Vigen is available to consult with other faculty, staff and students regarding study design, data management and statistical analysis.
Doctor of Philosophy (PhD)
2007 | University of Southern California
Master of Science (MS)
2003 | University of Southern California
Master of Science (MS)
1979 | University of Illinois at Chicago
Bachelor of Arts (BA)
1977 | University of California, San Diego
Roll, S. C., Hardison, M. E., Vigen, C., & Black, D. S. (2020). Mindful body scans and sonographic biofeedback as preparatory activities to address patient psychological states in hand therapy: A pilot study. Hand Therapy, 25(3), 98-106. https://doi.org/10.1177/1758998320930752 Show abstract
Introduction. Translational evidence for mind–body interventions in hand therapy is limited. This pilot study aimed to determine potential benefits of including a mindful body scan or sonographic biofeedback at the outset of a hand therapy session on key psychological states.
Methods. A randomized, repeated-measures, cross-over design was used to evaluate a mindful body scan and sonographic biofeedback at the outset of a hand therapy session. Measures of pain, anxiety, and stress (i.e. salivary cortisol) were obtained from 21 hand therapy patients at the start, after 20 min, and at the end of each of three 60-min treatments. Trends were examined, and mixed-effects regression compared effects across time within and across the sessions for each of the outcome measures.
Results. For all intervention types, anxiety and stress decreased across the treatment session (p < 0.001); no statistically significant changes were noted in pain. Using either mind–body intervention before standard care resulted in a meaningful decrease and statistical trend toward improvement in stress. The use of a mindful body scan produced an immediate, statistically significant reduction in anxiety (β = − 0.14, p = 0.03), a lowered level that was maintained throughout the therapy session.
Discussion. These data provide preliminary support for integrating mind–body interventions as preparatory activities in hand therapy. Mindful body scans may prepare patients for therapeutic interventions by more quickly reducing anxiety, and the use of either intervention may reduce patient stress more than would occur during a standard care session. These effects should be evaluated in an adequately powered clinical trial.
Keywords. Therapeutics, integrative health, sonography, mindfulness.
Carandang, K., Vigen, C. L., Ortiz, E., & Pyatak, E. A. (2020). Re-conceptualizing functional status through experiences of young adults with inflammatory arthritis. Rheumatology International, 40(2), 273-282. https://doi.org/10.1007/s00296-019-04368-8 Show abstract
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.
Keywords. Health status, Quality of life, Juvenile idiopathic arthritis, Rheumatoid arthritis, Young adult, Patient reported outcome
Lee, H. Y., Vigen, C., Zwaigenbaum, L., Bryson, S., Smith, I., Brian, J., Watson, L. R., Crais, E. R., Turner-Brown, L., Reznick, J. S., & Baranek, G. T. (2019). The performance of the First Year Inventory (FYI) screening on a sample of high-risk 12-month-olds diagnosed with autism spectrum disorder (ASD) at 36 months. Journal of Autism and Developmental Disorders, 49(12), 4957-4973. https://doi.org/10.1007/s10803-019-04208-5 Show abstract
This study examined the performance of the First Year Inventory (FYI; version 2.0), a community-normed parent-reported screening instrument, in a high-risk (HR) sample of 12-month-olds with older siblings diagnosed with autism spectrum disorder (ASD). The FYI 2.0 was completed by parents of 86 HR infants and 35 low-risk control infants at age 12 months, followed by clinical diagnosis at 36 months. HR infants later diagnosed with ASD had significantly higher FYI 2.0 risk scores in both the social-communication and sensory-regulatory domains than typically developing infants. New FYI 2.0 cutoff scores for HR sample were explored by evaluating various cutoff options after considering tradeoffs between sensitivity and specificity and sample characteristics.
Pyatak, E., King, M., Vigen, C. L., Salazar, E., Díaz, J., Schepens Niemiec, S. L., Blanchard, J., Jordan, K., Banerjee, J., & Shukla, J. (2019). Addressing diabetes in primary care: Hybrid effectiveness–implementation study of Lifestyle Redesign® occupational therapy. American Journal of Occupational Therapy, 73(5), 7305185020p1-7305185020p12. https://doi.org/10.5014/ajot.2019.037317 Show abstract
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.
Carlson, M., Vigen, C. L., Rubayi, S., Blanche, E. I., Blanchard, J., Atkins, M., Bates-Jensen, B., Garber, S. L., Pyatak, E. A., Díaz, J., Floríndez, L. I., Hay, J. W., Mallinson, T., Unger, J. B., Azen, S. P., Scott, M., Cogan, A., & Clark, F. (2019). Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study. Journal of Spinal Cord Medicine, 42(1), 2–19. https://doi.org/10.1080/10790268.2017.1313931 Show abstract
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.
Schepens Niemiec, S. L., Blanchard, J., Vigen, C. L., Martínez, J., Guzmán, L., Fluke, M., & Carlson, M. (2019). A pilot study of the ¡Vivir Mi Vida! lifestyle intervention for rural-dwelling, late-midlife Latinos: Study design and protocol. OTJR: Occupation, Participation and Health, 39(1), 5-13. https://doi.org/10.1177/1539449218762728 Show abstract
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.
Sleight, A. G., Cogan, A. M., Hill, V. A., Pyatak, E. A., Díaz, J., Floríndez, L. I., Blanchard, J., Vigen, C., Garber, S. L., & Clark, F. A. (2019). Factors protecting against pressure injuries in medically underserved adults with spinal cord injury: A qualitative study. Topics in Spinal Cord Injury Rehabilitation, 25(1), 31-40. https://doi.org/10.1310/sci2501-31 Show abstract
Background. Pressure injuries negatively impact quality of life and participation for individuals with spinal cord injury (SCI).
Objective. To examine the factors that may protect against the development of medically serious pressure injuries in adults with SCI.
Methods. A qualitative analysis was conducted using treatment notes regarding 50 socioeconomically disadvantaged individuals who did not develop medically serious pressure injuries during a 12-month pressure injury prevention intervention program.
Results. Eight types of potentially protective factors were identified: meaningful activity, motivation to prevent negative health outcomes, stability/resources, equipment, communication and self-advocacy skills, personal traits, physical factors, and behaviors/activities.
Conclusions. Some protective factors (e.g., personal traits) may be inherent to certain individuals and nonmodifiable. However, future interventions for this population may benefit from a focus on acquisition of medical equipment and facilitation of sustainable, health-promoting habits and routines. Substantive policy changes may be necessary to facilitate access to adequate resources, particularly housing and equipment, for socioeconomically disadvantaged individuals with SCI. Further research is needed to understand the complex interplay of risk and protective factors for pressure injuries in adults with SCI, particularly in underserved groups.
Pyatak, E. A., Carlson, M., Vigen, C. L., Blanchard, J., Schepens Niemiec, S., Sideris, J., & Baranek, G. T. (2019). Contextualizing the positive effects of the Well Elderly 2 trial: A response to Schelly and Ohl (2019). American Journal of Occupational Therapy, 73, 7306205100. https://doi.org/10.5014/ajot.2019.038752 Show abstract
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.
Schepens Niemiec, S. L., Blanchard, J., Vigen, C., Martínez, J., Guzmán, L., Concha, A., Fluke, M., & Carlson, M. (2018). 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. Primary Health Care Research & Development, 19, 448-463. https://doi.org/10.1017/S1463423617000901 Show abstract
Aim. The 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.
Findings. Participants 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.
Juang, C., Knight, B. G., Carlson, M., Schepens Niemiec, S. L., Vigen, C., & Clark, F. A. (2018). Understanding the mechanisms of change in a lifestyle intervention for older adults. The Gerontologist, 58(2), 353–361. https://doi.org/10.1093/geront/gnw152 Show abstract
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.
Weigensberg, M. J., Vigen, C., Sequeira, P., Spruijt-Metz, D., Juarez, M., Florindez, D., Provisor, J., Peters, A., & Pyatak, E. A. (2018). Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Global Advances in Health and Medicine, 7, 2164956118761808. https://doi.org/10.1177/2164956118761808 Show abstract
Background. The transition of young adults with type 1 diabetes (T1D) from pediatric to adult care is challenging and frequently accompanied by worsening of diabetes-related health. To date, there are no reports which prospectively assess the effects of theory-based psycho-behavioral interventions during the transition period neither on glycemic control nor on psychosocial factors that contribute to poor glycemic control. Therefore, the overall aim of this study was to develop and pilot test an integrative group intervention based on the underlying principles of self-determination theory (SDT), in young adults with T1D.
Methods. Fifty-one young adults with T1D participated in an education and case management-based transition program, of which 9 took part in the Diabetes Empowerment Council (DEC), a 12-week holistic, multimodality facilitated group intervention consisting of “council” process based on indigenous community practices, stress-reduction guided imagery, narrative medicine modalities, simple ritual, and other integrative modalities. Feasibility, acceptability, potential mechanism of effects, and bio-behavioral outcomes were determined using mixed qualitative and quantitative methods.
Results. The intervention was highly acceptable to participants, though presented significant feasibility challenges. Participants in DEC showed significant reductions in perceived stress and depression, and increases in general well-being relative to other control participants. Reduction in perceived stress, independent of intervention group, was associated with reductions in hemoglobin A1C. A theoretical model explaining the effects of the intervention included the promotion of relatedness and autonomy support, 2 important aspects of SDT.
Conclusions. The DEC is a promising group intervention for young adults with T1D going through transition to adult care. Future investigations will be necessary to resolve feasibility issues, optimize the multimodality intervention, determine full intervention effects, and fully test the role of the underlying theoretical model of action.
Vigen, C. L., Carandang, K., Blanchard, J., Sequeira, P. A., Wood, J. R., Spruijt-Metz, D., Whittemore, R., Peters, A. L., & Pyatak, E. A. (2018). Psychosocial and behavioral correlates of A1C and quality of life among young adults with diabetes. The Diabetes Educator, 44(6), 489–500. https://doi.org/10.1177/0145721718804170 Show abstract
Purpose. The purpose of this study was to evaluate relationships between behavioral and psychosocial constructs, A1C, and diabetes-dependent quality of life (DQoL) among low-socioeconomic status, ethnically diverse young adults with diabetes.
Methods. Using baseline data of 81 participants in the Resilient, Empowered, Active Living (REAL) randomized controlled trial, behavioral, cognitive, affective, and experiential variables were correlated with A1C and DQoL while adjusting for demographic characteristics, and these relationships were examined for potential effect modification.
Results. The data indicate that depressive symptoms and satisfaction with daily activities are associated with both A1C and DQoL, while diabetes knowledge and participation in daily activities are associated with neither A1C nor DQoL. Two constructs, diabetes distress and life satisfaction, were associated with DQoL and were unrelated to A1C, while 2 constructs, self-monitoring of blood glucose and medication adherence, were associated with A1C but unrelated to DQoL. These relationships were largely unchanged by adjusting for demographic characteristics, while numerous effect modifications were found.
Conclusion. The data suggest that when tailoring interventions, depressive symptoms and satisfaction with daily activities may be particularly fruitful intervention targets, as they represent modifiable risk factors that are associated with both A1C and DQoL.
Pyatak, E. A., Carandang, K., Vigen, C. L., Blanchard, J., Díaz, J., Concha-Chavez, A., Sequeira, P. A., Wood, J. R., Whittemore, R., Spruijt-Metz, D., & Peters, A. L. (2018). Occupational therapy intervention improves glycemic control and quality of life among young adults with diabetes: The Resilient, Empowered, Active Living With Diabetes (REAL Diabetes) randomized controlled trial. Diabetes Care, 41(4), 696-704. https://doi.org/10.2337/dc17-1634 Show abstract
Objective. To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes.
Research Design and Methods. Eighty-one young adults (age 22.6 ± 3.5 years; hemoglobin A1c [HbA1c] = 10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of seven content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA1c; secondary outcomes included diabetes self-care, diabetes-related quality of life (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests.
Results. Intent-to-treat analyses showed that IG participants showed significant improvement in HbA1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, P = 0.01), diabetes-related QOL (+0.7 vs. +0.15, P = 0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, P = 0.05) as compared with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported.
Conclusions. The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes.
Pyatak, E., Hernandez, R., Díaz, J., Carandang, K., Blanchard, J., & Vigen, C. (2018, April). Habit formation in an occupational therapy self-management intervention: The Resilient, Empowered, Active Living (REAL Diabetes) study. Paper presented at the meeting of the Society of Behavioral Medicine, New Orleans, LA.
Wu, A. H., Vigen, C. L., Butler, L. M., & Tseng, C.-C. (2017). Metabolic conditions and breast cancer risk among Los Angeles County Filipina Americans compared with Chinese and Japanese Americans. International Journal of Cancer, 141(12), 2450-2461. https://doi.org/10.1002/ijc.31018 Show abstract
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.
Pyatak, E. A., Sequeira, P. A., Vigen, C. L., Weigensberg, M. J., Wood, J. R., Montoya, L., Ruelas, V., & Peters, A. L. (2017). Clinical and psychosocial outcomes of a structured transition program among young adults with type 1 diabetes. Journal of Adolescent Health, 60(2), 212-218. https://doi.org/10.1016/j.jadohealth.2016.09.004 Show abstract
Purpose. We identified and treated young adults with type 1 diabetes who had been lost to follow-up during their transfer from pediatric to adult care, comparing their clinical, psychosocial, and health care utilization outcomes to participants receiving continuous care (CC) throughout the transition to adult care.
Methods. Individuals in their last year of pediatric care (CC group, n = 51) and individuals lost to follow-up in the transfer to adult care ("lapsed care" [LC] group, n = 24) were followed prospectively for 12 months. All participants were provided developmentally tailored diabetes education, case management, and clinical care through a structured transition program.
Results. At baseline, LC participants reported lapses in care of 11.6 months. Compared with CC participants, they had higher hemoglobin A1C (A1C; p = .005), depressive symptoms (p = .05), incidence of severe hypoglycemia (p = .005), and emergency department visits (p = .004). At 12-month follow-up, CC and LC participants did not differ on the number of diabetes care visits (p = .23), severe hypoglycemia (no events), or emergency department visits (p = .22). Both groups' A1C improved during the study period (CC: p = .03; LC: p = .02). LC participants' depressive symptoms remained elevated (p = .10), and they reported a decline in life satisfaction (p = .007). There was greater loss to follow-up in the LC group (p = .04).
Conclusions. Our study suggests that, for young adults with a history of lapses in care, a structured transition program is effective in lowering A1C, reducing severe hypoglycemia and emergency department utilization, and improving uptake of routine diabetes care. Loss to follow-up and psychosocial concerns remain significant challenges in this population.
Pyatak, E. A., Carandang, K., Vigen, C., Blanchard, J., Sequeira, P. A., Wood, J. R., Spruijt-Metz, D., Whittemore, R., & Peters, A. L. (2017). Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults. Contemporary Clinical Trials, 54, 8-17. https://doi.org/10.1016/j.cct.2016.12.025 Show abstract
Overview. This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist.
Methods. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity.
Results. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence.
Discussion. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs.
Wu, A. H., Vigen, C. L., Lee, E., Tseng, C.-C., & Butler, L. M. (2016). Traditional breast cancer risk factors in Filipina Americans compared with Chinese and Japanese Americans in Los Angeles County. Cancer Epidemiology, Biomarkers & Prevention, 25(12), 1572–1586. https://doi.org/10.1158/1055-9965.EPI-16-0203 Show abstract
Background. Filipina Americans have one of the highest breast cancer incidence rates among Asian Americans for poorly understood reasons.
Methods. Breast cancer risk factors were investigated in a population-based study of Filipina (790 cases, 587 controls), Japanese (543 cases, 510 controls), and Chinese (913 cases, 904 controls) Americans. Cases were identified by the Los Angeles County Cancer Surveillance Program, and controls were matched to cases on age, ethnicity, and neighborhood. Multivariable conditional logistic regression was performed by Asian ethnicity.
Results. In Filipina, Chinese, and Japanese Americans, breast cancer risk decreased significantly with increasing parity (all Ptrend < 0.0001). Breast cancer risk increased with increasing quartiles of cumulative menstrual months in premenopausal (Ptrend = 0.019) and postmenopausal Filipina (Ptrend = 0.008), in premenopausal (Ptrend = 0.0003) but not postmenopausal Chinese (Ptrend = 0.79), and in neither premenopausal (Ptrend = 0.092) nor postmenopausal (Ptrend = 0.75) Japanese Americans. For postmenopausal Filipina and Japanese, greater weight gain since age 18 (Ptrend = 0.019 and 0.053, respectively), high current body mass index (both Ptrend < 0.01), and greater waist circumferences (both Ptrend < 0.04) were statistically significant; these associations were weaker for postmenopausal Chinese women.
Conclusions. Cumulative menstrual months and body size factors were statistically significant risk factors for Filipina. Total menstrual months were associated with breast cancer among Chinese but not for Japanese, while body size factors were significantly associated with risk among Japanese but not among Chinese.
Impact. Characterization of breast cancer risk factors in Filipina will help to generate hypotheses for their high breast cancer incidence.
Carandang, K., Pyatak, E. A., & Vigen, C. P. (2016). Systematic review of educational interventions for rheumatoid arthritis. American Journal of Occupational Therapy, 70(6), 7006290020p1-7006290020p12. https://doi.org/10.5014/ajot.2016.021386 Show abstract
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.
Sposto, R., Keegan, T. H., Vigen, C. L., Kwan, M. L., Bernstein, L., John, E. M., Cheng, I., Yang, J., Koo, J., Kurian, A. W., Caan, B. J., Lu, Y., Monroe, K. R., Shariff-Marco, S., Gomez, S. L., & Wu, A. H. (2016). The effect of patient and contextual characteristics on racial/ethnic disparity in breast cancer mortality. Cancer Epidemiology, Biomarkers & Prevention, 25(7), 1064-1072. https://doi.org/10.1158/1055-9965.EPI-15-1326 Show abstract
Background. Racial/ethnic disparity in breast cancer–specific mortality in the United States is well documented. We examined whether accounting for racial/ethnic differences in the prevalence of clinical, patient, and lifestyle and contextual factors that are associated with breast cancer–specific mortality can explain this disparity.
Methods. The California Breast Cancer Survivorship Consortium combined interview data from six California-based breast cancer studies with cancer registry data to create a large, racially diverse cohort of women with primary invasive breast cancer. We examined the contribution of variables in a previously reported Cox regression baseline model plus additional contextual, physical activity, body size, and comorbidity variables to the racial/ethnic disparity in breast cancer–specific mortality.
Results. The cohort comprised 12,098 women. Fifty-four percent were non-Latina Whites, 17% African Americans, 17% Latinas, and 12% Asian Americans. In a model adjusting only for age and study, breast cancer–specific HRs relative to Whites were 1.69 (95% CI, 1.46–1.96), 1.00 (0.84–1.19), and 0.52 (0.33–0.85) for African Americans, Latinas, and Asian Americans, respectively. Adjusting for baseline-model variables decreased disparity primarily by reducing the HR for African Americans to 1.13 (0.96–1.33). The most influential variables were related to disease characteristics, neighborhood socioeconomic status, and smoking status at diagnosis. Other variables had negligible impact on disparity.
Conclusions. Although contextual, physical activity, body size, and comorbidity variables may influence breast cancer–specific mortality, they do not explain racial/ethnic mortality disparity.
Impact. Other factors besides those investigated here may explain the existing racial/ethnic disparity in mortality.
Leland, N. E., Fogelberg, D., Sleight, A., Mallinson, T., Vigen, C., Blanchard, J., Carlson, M., & Clark, F. (2016). Napping and nighttime sleep: Findings from an occupation-based intervention. American Journal of Occupational Therapy, 70(4), 7004270010p1-7. https://doi.org/10.5014/ajot.2016.017657 Show abstract
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.
Cogan, A. M., Blanchard, J., Garber, S. L., Vigen, C. L., Carlson, M., & Clark, F. A. (2016). Systematic review of behavioral and educational interventions to prevent pressure ulcers in adults with spinal cord injury. Clinical Rehabilitation, 31(7), 871-880. https://doi.org/10.1177/0269215516660855 Show abstract
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.
Vigen, C. L., Kwan, M. L., John, E. M., Gomez, S. L., Keegan, T. H., Lu, Y., Shariff-Marco, S., Monroe, K. R., Kurian, A. W., Cheng, I., Caan, B. J., Lee, V. S., Roh, J. M., Bernstein, L., Sposto, R., & Wu, A. H. (2016). Validation of self-reported comorbidity status of breast cancer patients with medical records: the California Breast Cancer Survivorship Consortium. Cancer Causes & Control, 27(3), 391-401. https://doi.org/10.1007/s10552-016-0715-8 Show abstract
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.
Clark, F. A., Blanchard, J., Sleight, A., Cogan, A., Eallonardo, L., Floríndez, L., Gleason, S., Heymann, R., Hill, V., Holden, A., Jackson, J. M., Mandel, D. R., Murphy, M., Proffitt, R., Niemiec, S. S., Vigen, C., & Zemke, R. (2015). Lifestyle redesign: The intervention tested in the USC Well Elderly Studies (2nd ed.). Bethesda, MD: American Occupational Therapy Association. Full text Show abstract
Reorganized, expanded, and updated, this new edition of the award-winning Lifestyle Redesign gives practical guidance in this preventative occupational therapy program for independent-living older adults. The work integrates the concept of the USC's landmark Well Elderly Studies, which determined that preventive occupational therapy greatly enhances the health and quality of life of independent-living older adults.
Twelve modules, including those on longevity, stress, home safety and navigating health care, illustrate how to incorporate the program into practice. Includes a flash drive with program handouts.
Shariff-Marco, S., Yang, J., John, E. M., Kurian, A. W., Cheng, I., Leung, R., Koo, J., Monroe, K. R., Henderson, B. E., Bernstein, L., Lu, Y., Kwan, M. L., Sposto, R., Vigen, C. L., Wu, A. H., Keegan, T. H., & Gomez, S. L. (2015). Intersection of race/ethnicity and socioeconomic status in mortality after breast cancer. Journal of Community Health, 40(6), 1287-1299. https://doi.org/10.1007/s10900-015-0052-y Show abstract
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.
Cheng, I., Shariff-Marco, S., Koo, J., Monroe, K. R., Yang, J., John, E. M., Kurian, A. W., Kwan, M. L., Henderson, B. E., Bernstein, L., Lu, Y., Sposto, R., Vigen, C. L., Wu, A. H., Gomez, S. L., & Keegan, T. H. (2015). Contribution of the neighborhood environment and obesity to breast cancer survival: The California Breast Cancer Survivorship Consortium. Cancer Epidemiology, Biomarkers & Prevention, 24(8), 1282-1290. https://doi.org/10.1158/1055-9965.EPI-15-0055 Show abstract
Little is known about neighborhood attributes that may influence opportunities for healthy eating and physical activity in relation to breast cancer mortality. We used data from the California Breast Cancer Survivorship Consortium and the California Neighborhoods Data System (CNDS) to examine the neighborhood environment, body mass index, and mortality after breast cancer. We studied 8,995 African American, Asian American, Latina, and non-Latina white women with breast cancer. Residential addresses were linked to the CNDS to characterize neighborhoods. We used multinomial logistic regression to evaluate the associations between neighborhood factors and obesity and Cox proportional hazards regression to examine associations between neighborhood factors and mortality. For Latinas, obesity was associated with more neighborhood crowding [quartile 4 (Q4) vs. Q1: OR, 3.24; 95% confidence interval (CI), 1.50–7.00]; breast cancer–specific mortality was inversely associated with neighborhood businesses (Q4 vs. Q1: HR, 0.46; 95% CI, 0.25–0.85) and positively associated with multifamily housing (Q3 vs. Q1: HR, 1.98; 95% CI, 1.20–3.26). For non-Latina whites, lower neighborhood socioeconomic status (SES) was associated with obesity [quintile 1 (Q1) vs. Q5: OR, 2.52; 95% CI, 1.31–4.84], breast cancer–specific (Q1 vs. Q5: HR, 2.75; 95% CI, 1.47–5.12), and all-cause (Q1 vs. Q5: HR, 1.75; 95% CI, 1.17–2.62) mortality. For Asian Americans, no associations were seen. For African Americans, lower neighborhood SES was associated with lower mortality in a nonlinear fashion. Attributes of the neighborhood environment were associated with obesity and mortality following breast cancer diagnosis, but these associations differed across racial/ethnic groups.
Sequeira, P. A., Pyatak, E. A., Weigensberg, M. J., Vigen, C. P., Wood, J. R., Ruelas, V., Montoya, L., Cohen, M., Speer, H., Clark, S., & Peters, A. L. (2015). Let's Empower and Prepare (LEAP): Evaluation of a structured transition program for young adults with type 1 diabetes. Diabetes Care, 38(8), 1412-1419. https://doi.org/10.2337/dc14-2577 Show abstract
Objective. To evaluate the efficacy of a structured transition program compared with usual care in improving routine follow-up, clinical, and psychosocial outcomes among young adults with type 1 diabetes.
Research Design and Methods. Eighty-one young adults in their last year of pediatric care were recruited from three clinics. Intervention group (IG) participants (n = 51) received a structured transition program incorporating tailored diabetes education, case management, group education classes, and access to a newly developed young adult diabetes clinic and transition website. Control group (CG) participants (n = 30) received usual care. The primary outcome was the number of routine clinic visits. Secondary outcomes included glycemic control, hypoglycemia, health-care use, and psychosocial well-being. Assessments were conducted at baseline, and 6 and 12 months.
Results. Limitations in CG follow-up prevented direct comparisons of adult care visits; however, at the 12-month follow-up among IG participants discharged from pediatric care (n = 32), 78% had one or more adult visits. Among IG participants, the total number of clinic visits did not differ between those who transitioned and those who remained in pediatric care (3.0 ± 1.24 vs. 3.11 ± 0.94, P = 0.74). IG compared with CG participants had improved glycemic control (-0.40 ± 1.16% vs. 0.42 ± 1.51% [4.4 ± 12.7 mmol/mol vs. 4.6 ± 16.5 mmol/mol], P = 0.01), incidence of severe hypoglycemia (0.0% vs. 16%, P = 0.02), and global well-being (P = 0.02) at 12 months.
Conclusions. A structured transition program was successful in facilitating transition to adult care without a decrease in clinical follow-up. Compared with usual care, the transition program facilitated improvements in glycemic control, hypoglycemia, and psychosocial well-being.
Lu, Y., John, E. M., Sullivan-Halley, J., Vigen, C. L., Gomez, S. L., Kwan, M. L., Caan, B. J., Lee, V. S., Roh, J. M., Shariff-Marco, S., Keegan, T. H., Kurian, A. W., Monroe, K. R., Cheng, I., Sposto, R., Wu, A. H., & Bernstein, L. (2015). History of recreational physical activity and survival after breast cancer: The California Breast Cancer Survivorship Consortium. American Journal of Epidemiology, 181(12), 944-955. https://doi.org/10.1093/aje/kwu466 Show abstract
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.
Wu, A. H., Kurian, A. W., Kwan, M. L., John, E. M., Lu, Y., Keegan, T. H., Gomez, S. L., Cheng, I., Shariff-Marco, S., Caan, B. J., Lee, V. S., Sullivan-Halley, J., Tseng, C.-C., Bernstein, L., Sposto, R., & Vigen, C. L. (2015). Diabetes and other comorbidities in breast cancer survival by race/ethnicity: The California Breast Cancer Survivorship Consortium (CBCSC). Cancer Epidemiology, Biomarkers & Prevention, 24(2), 361-368. https://doi.org/10.1158/1055-9965.EPI-14-1140 Show abstract
Background. The role of comorbidities in survival of patients with breast cancer has not been well studied, particularly in non-white populations.
Methods. We investigated the association of specific comorbidities with mortality in a multiethnic cohort of 8,952 breast cancer cases within the California Breast Cancer Survivorship Consortium (CBCSC), which pooled questionnaire and cancer registry data from five California-based studies. In total, 2,187 deaths (1,122 from breast cancer) were observed through December 31, 2010. Using multivariable Cox proportional hazards regression, we estimated HRs and 95% confidence intervals (CI) for overall and breast cancer–specific mortality associated with previous cancer, diabetes, high blood pressure (HBP), and myocardial infarction.
Results. Risk of breast cancer–specific mortality increased among breast cancer cases with a history of diabetes (HR, 1.48; 95% CI, 1.18–1.87) or myocardial infarction (HR, 1.94; 95% CI, 1.27–2.97). Risk patterns were similar across race/ethnicity (non-Latina white, Latina, African American, and Asian American), body size, menopausal status, and stage at diagnosis. In subgroup analyses, risk of breast cancer–specific mortality was significantly elevated among cases with diabetes who received neither radiotherapy nor chemotherapy (HR, 2.11; 95% CI, 1.32–3.36); no increased risk was observed among those who received both treatments (HR, 1.13; 95% CI, 0.70–1.84; Pinteraction = 0.03). A similar pattern was found for myocardial infarction by radiotherapy and chemotherapy (Pinteraction = 0.09).
Conclusion. These results may inform future treatment guidelines for patients with breast cancer with a history of diabetes or myocardial infarction.
Impact. Given the growing number of breast cancer survivors worldwide, we need to better understand how comorbidities may adversely affect treatment decisions and ultimately outcome.
Pyatak, E. A., Sequeira, P. A., Whittemore, R., Vigen, C. P., Peters, A. L., & Weigensberg, M. J. (2014). Challenges contributing to disrupted transition from paediatric to adult diabetes care in young adults with type 1 diabetes. Diabetic Medicine, 31(12), 1615-1624. https://doi.org/10.1111/dme.12485 Show abstract
Aim. To examine challenges contributing to disruptions in care during the transition from paediatric to adult care among young adults with Type 1 diabetes who are primarily in ethnic minority groups and have low socio-economic status.
Methods. Participants (n = 20) were newly enrolled patients in a transition clinic for young adults with Type 1 diabetes with a history of loss to medical follow-up. Participants completed qualitative semi-structured interviews detailing their transition experiences in addition to demographic, HbA1c and psychosocial measures. Descriptive statistics were completed for quantitative data, and narrative thematic analysis of interviews was used to identify common themes. A mixed-method analysis was used to identify the associations between stressors identified in interviews and clinical and psychosocial variables.
Results. Three categories of challenges contributing to loss to follow-up were identified: psychosocial challenges, health provider and health system challenges and developmental challenges. Participants experienced a high degree of stressful life circumstances which were associated with higher HbA1c (r = 0.60, P = 0.005), longer duration of loss to follow-up (r = 0.51, P = 0.02), greater emergency department utilization (r = 0.45, P = 0.05), and lower life satisfaction (r = -0.62, P = 0.003).
Conclusions. A confluence of challenges, including stressful life circumstances, healthcare system barriers and the developmental trajectory of young adulthood, contributes to a high risk of loss to follow-up and poor health in this population of young adults with Type 1 diabetes. An integrated approach to transition addressing medical and psychosocial needs may facilitate improved follow-up and health outcomes in clinical settings.
Mallinson, T., Schepens Niemiec, S. L., Carlson, M., Leland, N., Vigen, C., Blanchard, J., & Clark, F. (2014). Development and validation of the activity significance personal evaluation (ASPEn) scale. Australian Occupational Therapy Journal, 61(6), 384-393. https://doi.org/10.1111/1440-1630.12155 Show abstract
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.
Carlson, M., Jackson, J., Mandel, D., Blanchard, J., Holguin, J., Lai, M. Y., Marterella, A., Vigen, C., Gleason, S., Lam, C., Azen, S., & Clark, F. (2014). Predictors of retention among African American and Hispanic older adult research participants in the Well Elderly 2 randomized controlled trial. Journal of Applied Gerontology, 33(3), 357-382. https://doi.org/10.1177/0733464812471444 Show abstract
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.
Clark, F., Pyatak, E. A., Carlson, M., Blanche, E. I., Vigen, C., Hay, J., Mallinson, T., Blanchard, J., Unger, J. B., Garber, S. L., Díaz, J., Floríndez, L. I., Atkins, M., Rubayi, S., & Azen, S. P. (2014). Implementing trials of complex interventions in community settings: The USC-Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS). Clinical Trials, 11(2), 218-229. https://doi.org/10.1177/1740774514521904 Show abstract
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.
Kwan, M. L., John, E. M., Caan, B. J., Lee, V. S., Bernstein, L., Cheng, I., Gomez, S. L., Henderson, B. E., Keegan, T. H., Kurian, A. W., Lu, Y., Monroe, K. R., Roh, J. M., Shariff-Marco, S., Sposto, R., Vigen, C., & Wu, A. H. (2014). Obesity and mortality after breast cancer by race/ethnicity: The California Breast Cancer Survivorship Consortium. American Journal of Epidemiology, 179(1), 95-111. https://doi.org/10.1093/aje/kwt233 Show abstract
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.
Wu, A. H., Gomez, S. L., Vigen, C., Kwan, M. L., Keegan, T. H., Lu, Y., Shariff-Marco, S., Monroe, K. R., Kurian, A. W., Cheng, I., Caan, B. J., Lee, V. S., Roh, J. M., Sullivan-Halley, J., Henderson, B. E., Bernstein, L., John, E. M., & Sposto, R. (2013). The California Breast Cancer Survivorship Consortium (CBCSC): Prognostic factors associated with racial/ethnic differences in breast cancer survival. Cancer Causes & Control, 24(10), 1821-1836. https://doi.org/10.1007/s10552-013-0260-7 Show abstract
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.
Wu, A. H., Lee, E., & Vigen, C. (2013). Soy isoflavones and breast cancer. American Society of Clinical Oncology Educational Book, 2013, 102-106. https://doi.org/10.1200/EdBook_AM.2013.33.102 Show abstract
The soybean and its products have been a staple in the Asian diet for centuries. Although intake of soy remains low in most Western populations, the use of soy isoflavone supplements has become commonplace, and an increasing number of food products contain soy ingredients. This review will present an updated summary of the observational results on soy isoflavones and risk of breast cancer development and outcome in patients with breast cancer. Results from soy intervention studies that have specifically examined the effects of soy on breast cell proliferation in breast tissues will be discussed. We will conclude by highlighting gaps in our knowledge on soy and breast cancer and issues that need to be addressed in future studies.
Wu, A. H., Vigen, C., Razavi, P., Tseng, C. C., & Stancyzk, F. Z. (2012). Alcohol and breast cancer risk among Asian-American women in Los Angeles County. Breast Cancer Research: BCR, 14(6), R151. https://doi.org/10.1186/bcr3363 Show abstract
Introduction. The role of alcohol and breast cancer risk in Asians has not been well studied. Recent studies suggest that even moderate alcohol intake may be associated with an increase in breast cancer risk, and this may be particularly relevant as alcohol intake is traditionally low among Asians.
Methods. We investigated the association between lifetime alcohol intake (including frequency, quantity, duration, timing, and beverage type) and breast cancer in a population-based case-control study of 2,229 Asian Americans diagnosed with incident breast cancer and 2,002 matched control women in Los Angeles County. Additionally, we examined the relation between current alcohol intake and serum concentrations of sex-hormones and growth factors in a subset of postmenopausal control women.
Results. Regular lifetime alcohol intake was significantly higher in US-born than non-US-born Asian Americans (P < 0.001) and almost twice as common in Japanese- than in Chinese- and Filipino-Americans (P < 0.001). Breast cancer risk increased with increasing alcohol intake among US-born Asian Americans; the odds ratios (ORs) per 5 grams per day and per 10 years of drinking were 1.21 (95% confidence interval (CI) 1.00 to 1.45) and 1.12 (95% CI, 0.98 to 1.28), respectively. Regular alcohol intake was a significant risk factor for Japanese-, but not for Chinese- and Filipino-Americans. Current consumers compared with nondrinkers showed lower concentrations of insulin-like growth factor binding protein 3 (P = 0.03) and nonsignificantly higher concentrations of estrone and androgens.
Conclusions. Regular lifetime alcohol intake is a significant breast cancer risk factor in US-born Asian Americans and Japanese Americans, emphasizing the importance of this modifiable lifestyle factor in traditionally low-risk populations.
Grimminger, P. P., Shi, M., Barrett, C., Lebwohl, D., Danenberg, K. D., Brabender, J., Vigen, C. L., Danenberg, P. V., Winder, T., & Lenz, H. J. (2012). TS and ERCC-1 mRNA expressions and clinical outcome in patients with metastatic colon cancer in CONFIRM-1 and -2 clinical trials. The Pharmacogenomics Journal, 12, 404-411. https://doi.org/10.1038/tpj.2011.29 Show abstract
To validate established cutoff levels of thymidylate synthase (TS) and excision repair cross-complementing (ERCC-1) intratumoral mRNA expressions in tumor samples from metastatic colorectal cancer (mCRC) patients treated with PTK787/ZK222584 (PTK/ZK). From 122 samples of patients with mCRC enrolled in CONFIRM-1 (Colorectal Oral Novel Therapy for the Inhibition of Angiogenesis and Retarding of Metastases) or CONFIRM-2, mRNA was isolated of microdissected formalin-fixed paraffin-embedded samples and quantitated using TaqMan-based technology. Existing TS and ERCC-1 cutoff levels were tested for their prognostic value in first-line and second-line therapy. TS expression was associated with overall survival (OS) in first-line, but not second-line therapy. ERCC-1 was associated with OS in patients treated with first-line and second-line FOLFOX4. In first-line FOLFOX4, combination of high TS and/or high ERCC-1 was associated with shorter OS. A correlation was observed between ERCC-1 expression and benefit from PTK/ZK+FOLFOX4 treatment. TS and ERCC-1 expression is associated with clinical outcome in mCRC. Baseline TS and ERCC-1 levels may allow the selection of patients who benefit from FOLFOX4 chemotherapy.
Baydur, A., Vigen, C., & Chen, Z. (2012). Expiratory flow limitation in obstructive sleep apnea and COPD: A quantitative method to detect pattern differences using the negative expiratory pressure technique. Open Respiratory Medicine Journal, 6, 111-120. https://doi.org/10.2174/1874306401206010111 Show abstract
Background. Expiratory flow limitation (EFL), determined by the negative expiratory pressure (NEP) technique, can exhibit overlapping patterns in COPD, obstructive sleep apnea (OSA) and non-OSA obesity. We assessed the ability of a quantitative method to assess EFL to discriminate COPD from obese and OSA patients during NEP (-2 to -3 cm H(2)O) testing.
Methods. EFL was quantified by measuring the area under the preceding control tidal breath (Vt) subtended by the NEP curve (%AUC). To quantify mean lost flow, the ratio of %AUC to percentage of control Vt over which EFL occurred (%EFL) (= %AUC/%EFL) was computed. Percent EFL, %AUC, and %AUC/%EFL was compared in 42 patients with COPD, 28 obese subjects without OSA, 50 with OSA (26 mild-moderate, 24 severe) and 19 control subjects, in seated and supine postures.
Results. All patients exhibited %EFL values significantly higher than control subjects, corrected for age and gender (ANOVA). All but the COPD group exhibited higher %EFL while supine, but not %AUC or %AUC/%EFL. Amongst seated subjects, %EFL was highest in COPD, and amongst supine groups, it was greatest in OSA and COPD. %AUC/%EFL was significantly higher in mild-moderate OSA than in COPD only while seated. %AUC or %AUC/%EFL did not discriminate amongst other cohorts in either posture.
Conclusions. Computation of %EFL helps distinguish EFL in COPD, obese and OSA patients from those of control subjects. Computation of %AUC and %AUC/%EFL is useful in determining the magnitude of extrathoracic FL in individuals with obesity and OSA, but does not distinguish between cohorts.
McDonald, A. E., & Vigen, C. (2012). Reliability and validity of the McDonald Play Inventory. American Journal of Occupational Therapy, 66(4), e52-e60. https://doi.org/10.5014/ajot.2012.002493 Show abstract
Objective. This study examined the ability of a two-part self-report instrument, the McDonald Play Inventory, to reliably and validly measure the play activities and play styles of 7- to 11-yr-old children and to discriminate between the play of neurotypical children and children with known learning and developmental disabilities.
Method. A total of 124 children ages 7–11 recruited from a sample of convenience and a subsample of 17 parents participated in this study.
Results. Reliability estimates yielded moderate correlations for internal consistency, total test intercorrelations, and test–retest reliability. Validity estimates were established for content and construct validity.
Conclusion. The results suggest that a self-report instrument yields reliable and valid measures of a child’s perceived play performance and discriminates between the play of children with and without disabilities.
Kim, J. S., Holtom, P., & Vigen, C. (2011). Reduction of catheter-related bloodstream infections through the use of a central venous line bundle: Epidemiologic and economic consequences. American Journal of Infection Control, 39(8), 640-646. https://doi.org/10.1016/j.ajic.2010.11.005 Show abstract
Background. Central venous lines (CVLs) are used extensively in intensive care units (ICUs) but can sometimes lead to catheter-related blood stream infections (CRBSIs). This study evaluated a "CVL bundle" to see whether the CRBSI rate would decrease, analyze any changes in the flora of CRBSIs, and project any decrease in health care costs.
Methods. The CVL bundle was implemented on all patients admitted to the ICU starting January 2008. Data from CRBSI rates from 2006 and 2007 were pooled to compare the intervention. A Poisson analysis generated a relative risk reduction. Determination of costs were made by taking the excess length of stay multiplied by other costs (supplies, medications, cost of replacement of CVL) at our institution.
Results. Overall infection rates decreased with an improvement in CRBSIs in all ICUs that participated. Although the proportion of gram-negative organisms did not change significantly, there was a decrease in the proportion of gram-positive infections (P = .05) and an increase in fungal infections (P = .04). The total excess cost per organism was determined by the following: total excess cost = excess length of stay + replacement of CVL + drug administration + antibiotic cost. The weighted excess cost took the total excess cost times a correction factor based on organism frequency. The total excess cost of any given CRBSI is approximately $32,254.
Conclusion. Preventing CRBSIs can improve patient care while reducing hospital stays, costs, and possible mortality. CVL bundles are fairly easy to perform with reproducible results.
Francis, B. A., Varma, R., Vigen, C., Lai, M. Y., Winarko, J., Nguyen, B., & Azen, S. (2011). Population and high-risk group screening for glaucoma: The Los Angeles Latino Eye Study. Investigative Ophthalmology & Visual Science, 52(9), 6257-6264. https://doi.org/10.1167/iovs.09-5126 Show abstract
Purpose. To evaluate the ability of various screening tests, both individually and in combination, to detect glaucoma in the general Latino population and high-risk subgroups.
Methods. The Los Angeles Latino Eye Study is a population-based study of eye disease in Latinos 40 years of age and older. Participants (n = 6082) underwent Humphrey visual field testing (HVF), frequency doubling technology (FDT) perimetry, measurement of intraocular pressure (IOP) and central corneal thickness (CCT), and independent assessment of optic nerve vertical cup disc (C/D) ratio. Screening parameters were evaluated for three definitions of glaucoma based on optic disc, visual field, and a combination of both. Analyses were also conducted for high-risk subgroups (family history of glaucoma, diabetes mellitus, and age ≥65 years). Sensitivity, specificity, and receiver operating characteristic curves were calculated for those continuous parameters independently associated with glaucoma. Classification and regression tree (CART) analysis was used to develop a multivariate algorithm for glaucoma screening.
Results. Preset cutoffs for screening parameters yielded a generally poor balance of sensitivity and specificity (sensitivity/specificity for IOP ≥21 mm Hg and C/D ≥0.8 was 0.24/0.97 and 0.60/0.98, respectively). Assessment of high-risk subgroups did not improve the sensitivity/specificity of individual screening parameters. A CART analysis using multiple screening parameters-C/D, HVF, and IOP-substantially improved the balance of sensitivity and specificity (sensitivity/specificity 0.92/0.92).
Conclusions. No single screening parameter is useful for glaucoma screening. However, a combination of vertical C/D ratio, HVF, and IOP provides the best balance of sensitivity/specificity and is likely to provide the highest yield in glaucoma screening programs.
Vigen, C. L., Mack, W. J., Keefe, R. S., Sano, M., Sultzer, D. L., Stroup, T. S., Dagerman, K. S., Hsiao, J. K., Lebowitz, B. D., Lyketsos, C. G., Tariot, P. N., Zheng, L., & Schneider, L. S. (2011). Cognitive effects of atypical antipsychotic medications in patients with Alzheimer's disease: Outcomes from CATIE-AD. American Journal of Psychiatry, 168(8), 831-839. https://doi.org/10.1176/appi.ajp.2011.08121844 Show abstract
Objective. The impact of the atypical antipsychotics olanzapine, quetiapine, and risperidone on cognition in patients with Alzheimer's disease is unclear. The authors assessed the effects of time and treatment on neuropsychological functioning during the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer's Disease study (CATIE-AD).
Method. CATIE-AD included 421 outpatients with Alzheimer's disease and psychosis or agitated/aggressive behavior who were randomly assigned to receive masked, flexible-dose olanzapine, quetiapine, risperidone, or placebo. Based on their clinicians' judgment, patients could discontinue the originally assigned medication and receive another randomly assigned medication. Patients were followed for 36 weeks, and cognitive assessments were obtained at baseline and at 12, 24, and 36 weeks. Outcomes were compared for 357 patients for whom data were available for at least one cognitive measure at baseline and one follow-up assessment that took place after they had been on their prescribed medication or placebo for at least 2 weeks.
Results. Overall, patients showed steady, significant declines over time in most cognitive areas, including in scores on the Mini-Mental State Examination (MMSE; -2.4 points over 36 weeks) and the cognitive subscale of the Alzheimer's Disease Assessment Scale (-4.4 points). Cognitive function declined more in patients receiving antipsychotics than in those given placebo on multiple cognitive measures, including the MMSE, the cognitive subscale of the Brief Psychiatric Rating Scale, and a cognitive summary score summarizing change on 18 cognitive tests.
Conclusions. In CATIE-AD, atypical antipsychotics were associated with worsening cognitive function at a magnitude consistent with 1 year's deterioration compared with placebo. Further cognitive impairment is an additional risk of treatment with atypical antipsychotics that should be considered when treating patients with Alzheimer's disease.
Salama, H., Zekri, A. R., Zern, M., Bahnassy, A., Loutfy, S., Shalaby, S., Vigen, C., Burke, W., Mostafa, M., Medhat, E., Alfi, O., & Huttinger, E. (2010). Autologous hematopoietic stem cell transplantation in 48 patients with end-stage chronic liver diseases. Cell Transplantation, 19(11), 1475-1486. https://doi.org/10.3727/096368910X514314 Show abstract
The only presently viable treatment for end-stage liver disease is whole organ transplantation. However, there are insufficient livers available. The aim of the present study is to provide autologous bone marrow-derived stem cells as a potential therapeutic for patients with end-stage cirrhosis. This is a retrospective chart review of autologous stem cell treatment in 48 patients, 36 with chronic end-stage hepatitis C-induced liver disease and 12 with end-stage autoimmune liver disease. For all patients, granulocyte colony-stimulating factor was administered to mobilize their hematopoietic stem cells. Following leukapheresis, CD34+ stem cells were isolated, amplified, and partially differentiated in culture, then reinjected into each subject via their hepatic artery or portal vein. Treatment was generally well tolerated with the expected moderate but transient bone pain from G-CSF in less than half of the patients. Three patients had serious treatment-related complications, and only 20.8% of these end-stage liver disease patients died during 12 months of follow up. For all patients there was a statistically significant decrease in ascites. There was clinical and biochemical improvement in a large percentage of patients who received the transplantation. In the viral group, there were marked changes in albumin (p = 0.0003), bilirubin (p = 0.04), INR (p = 0.0003), and ALT levels (p = 0.02). In the autoimmune group, values also improved significantly for albumin (p = 0.001), bilirubin (p = 0.002), INR (p = .0005), and ALT levels (p = 0.003). These results suggest that autologous CD34+ stem cell transplantation may be safely administered and appears to offer some therapeutic benefit to patients with both viral and autoimmune-induced end-stage liver disease.
Zheng, L., Mack, W. J., Dagerman, K. S., Hsiao, J. S., Lebowitz, B. D., Lyketsos, C. G., Stroup, T. S., Sultzer, D. L., Tariot, P. N., Vigen, C., & Schneider, L. S. (2009). Metabolic changes associated with second-generation antipsychotic use in Alzheimer's disease patients: The CATIE-AD study. American Journal of Psychiatry, 166(5), 583-590. https://doi.org/10.1176/appi.ajp.2008.08081218 Show abstract
Objective. The second-generation antipsychotics are associated with metabolic abnormalities in patients with schizophrenia. Elderly patients with Alzheimer's disease are frequently treated with these antipsychotics, but limited data are available on their metabolic effects.
Method. The authors assessed 186 male and 235 female Alzheimer's disease outpatients from the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD) for changes in weight, waist circumference, blood pressure, fasting glucose, and lipids in relation to duration of second-generation antipsychotic use (i.e., olanzapine, quetiapine, and risperidone) throughout the 36-week trial, using logistic regression and mixed-effects models.
Results. Women showed significant weight gain (0.14 lb/week of use) while change was nonsignificant in men. Clinically significant weight gain (i.e., ≥ 7% of body weight) was seen among patients with antipsychotic use ≤ 12 weeks (odds ratio [OR]=1.56, 95% CI=0.53 to 4.58), between 12 and 24 weeks (OR=2.89, 95% CI=0.97 to 8.64), and > 24 weeks (OR=3.38, 95% CI=1.24 to 9.23) relative to patients who did not use antipsychotics during the trial. Olanzapine and quetiapine treatments were significantly associated with weight gain (0.12 and 0.14 lb/week, respectively). In addition, olanzapine was significantly associated with decreases in HDL cholesterol (-0.19 mg/dl/week) and increased girth (0.07 inches/week) relative to the placebo group. No treatment effects were noted for changes in blood pressure, glucose, and triglycerides.
Conclusion. Second-generation antipsychotic use was associated with weight gain in women, with olanzapine and quetiapine in particular, and with unfavorable change in HDL cholesterol and girth with olanzapine. The potential consequences of these effects suggest that patients with Alzheimer's disease treated with second-generation antipsychotics should be monitored closely.
Nowicki, M. J., Vigen, C., Mack, W. J., Seaberg, E., Landay, A., Anastos, K., Young, M., Minkoff, H., Greenblatt, R., & Levine, A. M. (2008). Association of cells with natural killer (NK) and NKT immunophenotype with incident cancers in HIV-infected women. AIDS Research and Human Retroviruses, 24(2), 163-168. https://doi.org/10.1089/aid.2007.0119 Show abstract
Evidence indicates that immunosupression is associated with the development of certain cancers. The pathogenesis of HIV disease includes an alteration in innate immunity, mediated through NK and NKT cells. The evaluation of innate immune status in HIV patients prior to cancer diagnosis may identify the specific immunological events preceding the development of malignant disease. We evaluated the association between immunophenotypically defined NK, NKT, and CD8+ cell percentages and incident malignancies in 1817 HIV(+) women in the Women's Interagency HIV Study (WIHS) who were followed for a median of 7.5 years. A total of 52 incident cancers of 20 different sites were identified. Compared to cancer-free women, cancer cases were older (p < 0.01), more likely to be anti-HCV(+) (p = 0.02), and had higher baseline median HIV RNA levels than controls. The CD8+, NK, and NKT percents at baseline were not related to cancer risk. However, when time-dependent values for NKT cells were used, higher levels of NKT cells were associated with a reduced risk of cancer (adjusted hazard ratio = 0.67, 95% CI = 0.50, 0.89 per NKT percentage point). In addition to the loss of CD4+ lymphocytes and an increased risk of opportunistic infections, HCV coinfected individuals may also experience alterations in innate immunity, including reduced NKT and NK cell number and possibly their function. In time-dependent analyses, increased numbers of NKT cells were associated with a reduced risk of cancer. HIV-induced innate immune dysfunction may contribute to the eventual emergence of cancer in the setting of existing coinfections and altered immunosurveillance.
Vigen, C., Hodis, H. N., Chandler, W. L., Lobo, R. A., & Mack, W. J. (2007). Postmenopausal oral estrogen therapy affects hemostatic factors, but does not account for reduction in the progression of subclinical atherosclerosis. Journal of Thrombosis and Haemostasis, 5(6), 1201-1208. https://doi.org/10.1111/j.1538-7836.2007.02547.x Show abstract
Background. Hemostatic factors influenced by postmenopausal hormone therapy may contribute to atherosclerosis. The Estrogen in the Prevention of Atherosclerosis Trial (EPAT), a 2-year, randomized, double-blind, placebo-controlled trial, demonstrated reduced subclinical atherosclerosis progression measured by change in common carotid artery intima-media thickness (CIMT) with unopposed oral 17β-estradiol.
Objectives. To assess the effect of postmenopausal hormone therapy on the levels of several hemostatic factors, and the relationship between these factors and the progression of subclinical atherosclerosis.
Patients and Methods. We measured tissue plasminogen activator (t-PA) antigen, factor (F) VII, D-dimer and albumin longitudinally, and plasminogen activator inhibitor type 1 (PAI-1) and fibrinogen at trial-end, in 186 postmenopausal women.
Results. Estradiol vs. placebo was associated with greater FVII and lower t-PA, albumin, PAI-1 and fibrinogen (all P ≤ 0.001), with no estradiol effect on D-dimer (P = 0.42). Only mean on-trial t-PA was positively associated with the absolute level of CIMT on-trial (r = 0.29, P < 0.0001), but this was attenuated with age and body mass index adjustment. No longitudinally measured hemostatic factor was associated with CIMT progression. However, higher CIMT during the trial was significantly related to increases in t-PA.
Conclusions. These results confirm previous findings regarding estrogen's effect on hemostatic factors and show that albumin is negatively associated with estrogen therapy. These hemostatic factors did not account for the reduction of CIMT progression with 17β-estradiol seen in EPAT. Atherosclerosis itself may affect levels of hemostatic factors (reverse causality), with subsequent involvement in atherosclerosis-associated thrombosis.
Anastos, K., Lu, D., Shi, Q., Tien, P. C., Kaplan, R. C., Hessol, N. A., Cole, S., Vigen, C., Cohen, M., Young, M., & Justman, J. (2007). Association of serum lipid levels with HIV serostatus, specific antiretroviral agents, and treatment regimens. Journal of Acquired Immune Deficiency Syndromes, 45(1), 34-42. https://doi.org/10.1097/QAI.0b013e318042d5fe Show abstract
Background. The effects of HIV infection, highly active antiretroviral therapy (HAART), and specific antiretroviral agents on lipoproteins in women are not well described.
Methods. In a cross-sectional substudy of the Women's Interagency HIV Study with 623 HIV-negative and 1556 HIV-positive women (636 untreated, 419 on non-protease inhibitor [PI] HAART, and 501 on PI-containing HAART), we performed multivariate analyses of associations among fasting lipoprotein levels, HIV infection, and HAART.
Results. Untreated HIV-positive women had lower high-density lipoprotein cholesterol (HDL-C) and higher triglycerides (TGs) but not lower low-density lipoprotein cholesterol (LDL-C) than HIV-negative women and were the most likely to have unfavorable HDL-C by National Cholesterol Education Program (NCEP) guidelines. PI HAART users had higher LDL-C than untreated HIV-infected women (107 vs. 100 mg/dL, P = 0.0006) and were the most likely to have unfavorable LDL-C and TGs by NCEP guidelines. HIV-negative women and non-PI HAART users had similar HDL-C levels (55 and 53 mg/dL, respectively), which were higher than those in untreated HIV-infected women and PI HAART users (42 and 49 mg/dL, respectively; P < 0.001 for all). Lamivudine, didanosine, nevirapine, and efavirenz were independently associated with higher HDL-C (P < 0.001 for all). Ritonavir, indinavir/ritonavir, and nelfinavir were associated with higher LDL-C (P < 0.01 for all). Stavudine, abacavir, and all ritonavir-containing regimens were associated with higher TGs (P < 0.05 for all), and tenofovir was associated with lower TGs (P = 0.009).
Conclusions. A dyslipidemic pattern was associated with HIV infection itself, was more severe in users of PI-containing HAART, but was not present in women taking non-PI HAART.
O'Connell, C. L., Boswell, W. D., Duddalwar, V., Caton, A., Mark, L. S., Vigen, C., & Liebman, H. A. (2006). Unsuspected pulmonary emboli in cancer patients: Clinical correlates and relevance. Journal of Clinical Oncology, 24(30), 4928-4932. https://doi.org/10.1200/JCO.2006.06.5870 Show abstract
Purpose. Advances in computed tomography (CT) scanning have led to the detection of unsuspected pulmonary emboli (PE) on routine cancer staging scans. We hypothesized that these patients had signs or symptoms suggestive of PE that may have been overlooked by their health care providers.
Patients and Methods. A retrospective chart review was performed on 59 patients found on routine cancer staging CT scans to have unsuspected PE. Information on patient demographics, malignancy characteristics, risk factors for venous thromboembolism (VTE), and symptoms was recorded. A retrospective case-control analysis was then performed using two age- and stage-matched control patients for each patient who had similar staging CT scans performed during the same period.
Results. Fifty-two patients with unsuspected PE were identified. Forty-four percent had signs or symptoms commonly associated with PE; when fatigue was included, 75% were symptomatic. Ninety-two control patients were identified for 46 of the case patients. Patients with unsuspected PE were significantly more likely to have had a prior history of VTE (20% v 3%; P = .007). The patients with PE were significantly more likely than control patients to complain of fatigue (54% v 20%; P = .0002) and shortness of breath (22% v 8%; P = .02). There was no difference between the groups in administration of chemotherapy within 30 days, central venous catheter use, or erythropoietin therapy.
Conclusion. Seventy-five percent of patients found to have unsuspected PE on cancer staging CT scans were symptomatic. Fatigue and shortness of breath were significantly more common in patients with unsuspected PE than in control patients.
Levine, A. M., Vigen, C., Gravink, J., Mack, W., Watts, C. H., & Liebman, H. A. (2006). Progressive prothrombotic state in women with advancing HIV disease. Journal of Acquired Immune Deficiency Syndromes, 42(5), 572-577. https://doi.org/10.1097/01.qai.0000230320.78288.79 Show abstract
Background. HIV-infected patients are at increased risk for venous thrombotic events (VTEs). We sought to determine if advancing stages of HIV were associated with coagulation abnormalities that could predispose to VTE.
Methods. Functional protein S, factor VIII activity, and lupus anticoagulant were assayed in 144 participants of the Women's Interagency HIV Study. Women with conditions associated with VTE (cancer, pregnancy, hormone use, acute infection, cancer, and autoimmune disease) were excluded. Subjects included 34 women with history of clinical AIDS, 11 with immunologic AIDS (CD4 count, <200 cells/dL), 49 with asymptomatic HIV, and 50 HIV-negative comparators.
Results. We found progressive decreases in protein S, when comparing HIV-negative women (median, 76%) to women with asymptomatic HIV (median, 67%), immunologic AIDS (median, 62%), or clinical AIDS (median, 46%; P < 0.0001). Similarly, advancing HIV was associated with stepwise increases in factor VIII, from a median of 116% in HIV-negative women to 149% in those with asymptomatic HIV, 196% in those with immunologic AIDS, and 211% in those with clinical AIDS (P < 0.0001). No subject had lupus anticoagulant.
Conclusions. Advancing HIV is associated with progressive abnormalities of protein S and factor VIII; both of which are associated with increased risk for VTE, thus providing a biologic mechanism for the increased prevalence of VTE in HIV.
Vigen, C., Bernstein, L., & Wu, A. H. (2006). Occupational physical activity and risk of adenocarcinomas of the esophagus and stomach. International Journal of Cancer, 118(4), 1004-1009. https://doi.org/10.1002/ijc.21419 Show abstract
Physical activity may have a role in many cancers, but little is known about its effect on esophageal and gastric adenocarcinoma risk. We investigated occupational physical activity and esophageal and gastric adenocarcinoma risk in a population-based, case-control study including 212 esophageal, 264 gastric cardia and 389 distal gastric cancer cases, and 1,330 controls in Los Angeles County. Lifetime occupational histories were obtained during in-person interviews, and total lifetime occupational activity (Total Activity Index) was calculated using US Census job codes classified as sedentary, or moderately or highly physically active. Average Annual Activity Index was a per-year Total Activity Index counterpart. Unconditional logistic regression was used to calculate odds ratios, 95% confidence intervals and trend tests adjusting for gender, race, age, birthplace, education, smoking, body mass index (BMI) and number of years worked. Esophageal adenocarcinoma risk tended to decrease with increasing Total Activity Index (OR = 0.67, 95% CI = 0.38,1.19 for highest versus lowest quartile), but neither gastric cardia nor distal gastric cancer was associated with the Total Activity Index. This inverse association held for esophageal adenocarcinoma (OR = 0.61, 95% CI = 0.38,0.99 for highest vs. lowest quartile) and modest associations were observed for gastric cardia (OR = 0.76, 95% CI = 0.49,1.18) and distal gastric cancer (OR = 0.77, 95% CI = 0.52,1.14) when based on Average Annual Activity Index before age 65 years. Analyses stratified by gender, race, age, BMI, education and years worked provided similar results. We found a modest protective effect of Total Activity Index on esophageal adenocarcinoma. Future studies with more complete information on occupational and recreational physical activity are needed to confirm and further investigate the suggested protective effect of physical activity on these tumor types.
Andel, R., Vigen, C., Mack, W. J., Clark, L. J., & Gatz, M. (2006). The effect of education and occupational complexity on rate of cognitive decline in Alzheimer's patients. Journal of the International Neuropsychological Society, 12(1), 147-152. https://doi.org/10.1017/S1355617706060206 Show abstract
We explored the effect of education and occupational complexity on the rate of cognitive decline (as measured by the Mini-Mental State Examination) in 171 patients with a confirmed Alzheimer's disease (AD) diagnosis. Complexity was measured as substantive complexity of work and complexity of work with data, people, and things. Average lifetime occupational complexity was calculated based on years at each occupation. Participants were followed for an average of 2.5 years and 3.7 visits. In multivariate mixed-effects models, high education, high substantive complexity, and high complexity of work with data and people predicted faster rates of cognitive decline, controlling for age, gender, native language, dementia severity, and entry into the analyses at initial versus follow-up testing. These results provide support for the concept of cognitive reserve according to which greater reserve may postpone clinical onset of AD but also accelerate cognitive decline after the onset.
Vigen, C., Hodis, H. N., Selzer, R. H., Mahrer, P. R., & Mack, W. J. (2005). Relation of progression of coronary artery atherosclerosis to risk of cardiovascular events (from the Monitored Atherosclerosis Regression Study). American Journal of Cardiology, 95(11), 1277-1282. https://doi.org/10.1016/j.amjcard.2005.01.068 Show abstract
We investigated whether change in coronary artery atherosclerosis as measured by quantitative coronary angiography is related to cardiovascular event risk. Although many studies have demonstrated the effectiveness of statins in decreasing atherosclerotic progression and cardiovascular event risk, a relation between coronary atherosclerotic progression and event risk has not been documented in clinical trials that have evaluated statin therapy. The Monitored Atherosclerosis Regression Study (MARS) was a randomized, double-blind, placebo-controlled trial designed to test whether lovastatin would decrease coronary atherosclerotic progression as measured by quantitative coronary angiography. We followed 173 subjects in the MARS who had minimum luminal diameter and percent diameter stenosis measured at the beginning and end of a 2-year intervention. Postintervention follow-up events over a mean period of 9.4 years were reported by subjects and verified by medical records. Two-year percent stenosis and minimum luminal diameter changes were tested in relation to clinical event risk in multivariate Cox's regression models. Events ascertained were (1) coronary death and myocardial infarction, (2) coronary death, myocardial infarction, coronary artery bypass grafting, and percutaneous transluminal coronary angioplasty, and (3) any cardiovascular event. Increased percent stenosis was associated with significantly increased hazard ratios (HRs) in all event categories (category 1 HR 1.55 per SD percent stenosis, p <0.01; category 2 HR 1.58, p <0.01; category 3 HR 1.47, p = 0.01). Conversely, event risks were decreased for subjects who had increased minimum luminal diameter (category 1 HR 0.79, p = 0.04) and were not associated with category 2 (HR 0.79, p = 0.12) or category 3 (HR 0.81, p = 0.17). These results indicate that quantitative coronary angiographic changes are associated with cardiovascular events and support the long-term benefit of early intervention to decrease atherosclerosis.