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1.  Dentists United to Extinguish Tobacco (DUET): a study protocol for a cluster randomized, controlled trial for enhancing implementation of clinical practice guidelines for treating tobacco dependence in dental care settings 
Background
Although dental care settings provide an exceptional opportunity to reach smokers and provide brief cessation advice and treatment to reduce oral and other tobacco-related health conditions, dental care providers demonstrate limited adherence to evidence-based guidelines for treatment of tobacco use and dependence.
Methods/Design
Guided by a multi-level, conceptual framework that emphasizes changes in provider beliefs and organizational characteristics as drivers of improvement in tobacco treatment delivery, the current protocol will use a cluster, randomized design and multiple data sources (patient exit interviews, provider surveys, site observations, chart audits, and semi-structured provider interviews) to study the process of implementing clinical practice guidelines for treating tobacco dependence in 18 public dental care clinics in New York City. The specific aims of this comparative-effectiveness research trial are to: compare the effectiveness of three promising strategies for implementation of tobacco use treatment guidelines—staff training and current best practices (CBP), CBP + provider performance feedback (PF), and CBP + PF + provider reimbursement for delivery of tobacco cessation treatment (pay-for-performance, or P4P); examine potential theory-driven mechanisms hypothesized to explain the comparative effectiveness of three strategies for implementation; and identify baseline organizational factors that influence the implementation of evidence-based tobacco use treatment practices in dental clinics. The primary outcome is change in providers’ tobacco treatment practices and the secondary outcomes are cost per quit, use of tobacco cessation treatments, quit attempts, and smoking abstinence.
Discussion
We hypothesize that the value of these promising implementation strategies is additive and that incorporating all three strategies (CBP, PF, and P4P) will be superior to CBP alone and CBP + PF in improving delivery of cessation assistance to smokers. The findings will improve knowledge pertinent to the implementation, dissemination, and sustained utilization of evidence-based tobacco use treatment in dental practices.
Trial registration
NCT01615237.
doi:10.1186/1748-5908-9-25
PMCID: PMC3936874  PMID: 24559178
Dental care; Clinical practice guidelines; Treatment of tobacco dependence; Tobacco cessation
2.  Using R and WinBUGS to fit a Generalized Partial Credit Model for developing and evaluating patient-reported outcomes assessments 
Statistics in medicine  2012;31(18):2010-2026.
The US Food and Drug Administration recently announced the final guidelines on the development and validation of Patient-Reported Outcomes (PROs) assessments in drug labeling and clinical trials. This guidance paper may boost the demand for new PRO survey questionnaires. Henceforth biostatisticians may encounter psychometric methods more frequently, particularly Item Response Theory (IRT) models to guide the shortening of a PRO assessment instrument. This article aims to provide an introduction on the theory and practical analytic skills in fitting a Generalized Partial Credit Model in IRT (GPCM). GPCM theory is explained first, with special attention to a clearer exposition of the formal mathematics than what is typically available in the psychometric literature. Then a worked example is presented, using self-reported responses taken from the International Personality Item Pool. The worked example contains step-by-step guides on using the statistical languages R and WinBUGS in fitting the GPCM. Finally, the Fisher information function of the GPCM model is derived and used to evaluate, as an illustrative example, the usefulness of assessment items by their information contents. This article aims to encourage biostatisticians to apply IRT models in the re-analysis of existing data and in future research.
doi:10.1002/sim.4475
PMCID: PMC3926129  PMID: 22362655
Item Response Theory; Generalized Partial Credit Model; Rasch Model
3.  Initial Reactions to Tobacco Use and Risk of Future Regular Use 
Nicotine & Tobacco Research  2012;15(2):509-517.
Introduction: Studies suggest that initial smoking pleasure influences future smoking behavior. We investigated how initial reactions to cigarettes or Swedish smokeless tobacco (snus) were associated with future use among 10,708 adults from the Swedish Twin Registry.
Methods: The Early Smoking Experience questionnaire captured physiologic reactions to initial tobacco use. Binary recursive partitioning (BRP) identified combinations of initial reactions predictive of regular tobacco use. Analyses, stratified by sex, were conducted separately among those who experimented with only cigarettes (EC), only snus (ES), and both products (EC+S).
Results: Among EC, 39.8% of men and 43.7% of women became smokers, while among ES, 78.6% of men and 53.7% of women became snus users. Among EC+S, 31.3% of men and 20.0% of women became dual users. BRP identified different reactions as predictive of future smoking for men (buzz) and women (dizziness, difficulty inhaling). No initial reaction predicted future snus use among men, but pleasant sensations, later age at first use, and relaxation predicted future snus use for women. Among EC+S, future exclusive use of either product was associated with a favorable initial reaction to that product. Dual users experienced higher prevalence of pleasant reactions and lower prevalence of unpleasant reactions in response to both products.
Conclusions: Our findings support that those who progress to regular tobacco use may be sensitive to the rewarding effects of nicotine but suggest that initial reactions differ by tobacco type. A high proportion of men became regular snus users regardless of initial reactions.
doi:10.1093/ntr/nts180
PMCID: PMC3612000  PMID: 22949572
4.  Changes in Forest Soil Properties in Different Successional Stages in Lower Tropical China 
PLoS ONE  2013;8(11):e81359.
Background
Natural forest succession often affects soil physical and chemical properties. Selected physical and chemical soil properties were studied in an old-growth forest across a forest successional series in Dinghushan Nature Reserve, Southern China.
Methodology/Principal Findings
The aim was to assess the effects of forest succession change on soil properties. Soil samples (0–20 cm depth) were collected from three forest types at different succession stages, namely pine (Pinus massoniana) forest (PMF), mixed pine and broadleaf forest (PBMF) and monsoon evergreen broadleaf forest (MEBF), representing early, middle and advanced successional stages respectively. The soil samples were analyzed for soil water storage (SWS), soil organic matter (SOM), soil microbial biomass carbon (SMBC), pH, NH4+-N, available potassium (K), available phosphorus (P) and microelements (available copper (Cu), available zinc (Zn), available iron (Fe) and available boron (B)) between 1999 and 2009. The results showed that SWS, SOM, SMBC, Cu, Zn, Fe and B concentrations were higher in the advanced successional stage (MEBF stage). Conversely, P and pH were lower in the MEBF but higher in the PMF (early successional stage). pH, NH4+-N, P and K declined while SOM, Zn, Cu, Fe and B increased with increasing forest age. Soil pH was lower than 4.5 in the three forest types, indicating that the surface soil was acidic, a stable trend in Dinghushan.
Conclusion/Significance
These findings demonstrated significant impacts of natural succession in an old-growth forest on the surface soil nutrient properties and organic matter. Changes in soil properties along the forest succession gradient may be a useful index for evaluating the successional stages of the subtropical forests. We caution that our inferences are drawn from a pseudo-replicated chronosequence, as true replicates were difficult to find. Further studies are needed to draw rigorous conclusions regarding on nutrient dynamics in different successional stages of forest.
doi:10.1371/journal.pone.0081359
PMCID: PMC3828269  PMID: 24244738
5.  Measurement of Affective and Activity Pain Interference Using the Brief Pain Inventory (BPI): Cancer and Leukemia Group B 70903* 
Pain medicine (Malden, Mass.)  2012;13(11):1417-1424.
Objective
The Brief Pain Inventory (BPI) was designed to yield separate scores for pain intensity and interference. It has been proposed that the pain interference factor can be further broken down into unique factors of affective (e.g., mood) and activity (e.g., work) interference. The purpose of this analysis was to confirm this affective/activity interference dichotomy.
Patients and Methods
A retrospective confirmatory factor analysis was completed for a sample of 184 individuals diagnosed with castrate-resistant prostate cancer (Age 40–86, M = 65.46, 77% White Non-Hispanic) who had been administered the BPI as part of Cancer and Leukemia Group B (CALGB) trial 9480. A one-factor model was compared against two-factor and three-factor models that were developed based on the design of the instrument.
Results
Root mean squared error of approximation (0.075), comparative fit index (0.971), and change in chi-square, given the corresponding change in degrees of freedom (13.33, p < .05) values for the three-factor model (i.e., pain intensity, activity interference, and affective interference) were statistically superior in comparison to the one- and two-factor models. This three-factor structure was found to be invariant across age, mean PSA and hemoglobin levels.
Conclusions
These results confirm that the BPI can be used to quantify the degree to which pain separately interferes with affective and activity aspects of a patient's everyday life. These findings will provide clinical trialists, pharmaceutical sponsors, and regulators with confidence in the flexibility of the BPI as they consider the use of this instrument to assist with understanding the patient experience as it relates to treatment.
doi:10.1111/j.1526-4637.2012.01498.x
PMCID: PMC3796944  PMID: 23110676
Measurement; Cancer Pain; Quality of Life
6.  Toward a greater understanding of breast cancer patients’ decisions to discuss cancer related internet information with their doctors: An exploratory study 
Patient education and counseling  2012;89(1):109-115.
Objective
To investigate differences between breast cancer patients who do and do not discuss cancer-related internet information (CRII) with their doctors.
Methods
70 breast cancer patients completed questionnaires regarding internet use, discussions about CRII, and the doctor-patient relationship.
Results
No significant differences were noted across patient, disease, or visit characteristics, or physician reliance between those who intended to discuss CRII and those who did not. Patients who intended to discuss CRII rated significantly higher pre-consultation anxiety levels. No significant differences in satisfaction, anxiety reduction, or trust in physician were found between patients who had discussed and those who had not. Patients’ reasons for discussing or not discussing are detailed.
Conclusion
Factors influencing patients’ decisions to discuss CRII are complex and differ from those identified as leading patients to seek internet information. Future research about internet discussions should investigate the impact of patients’ preferred role in treatment, the doctor-patient relationship, anxiety level, attributes of CRII, and physician trust.
Practice Implications
Understanding the characteristics of patients who do and do not discuss internet information is important given the impact internet information has on healthcare communication and the doctor-patient relationship, including the development of interventions aimed at improving such interactions.
doi:10.1016/j.pec.2012.05.008
PMCID: PMC3462296  PMID: 22722063
internet; doctor-patient communication; breast cancer
7.  Testing the utility of a cancer clinical trial specific Question Prompt List (QPL-CT) during oncology consultations 
Patient education and counseling  2012;88(2):311-317.
Objective
A Question Prompt List (QPL) is a proven, simple intervention to aid patients to be active participants in consultations with their physicians by asking questions. We aimed to further develop and test the efficacy of a targeted QPL for clinical trials (QPL-CT).
Methods
Breast, Lung and Genitourinary cancer patients who were facing a discussion about a therapeutic clinical trial completed short pre- and post-consultation questionnaires and used the QPL-CT in their discussions with their oncologists.
Results: 30 participants were recruited from 6 oncologists
All QPL-CT questions were selected by at least one-third of participants. Participants mostly wanted and asked questions about personal trial benefit. Oncologists provided information about personal benefit to varying degrees, thus patients did not ask some questions. Patients were still left with some unasked and unanswered questions.
Conclusion
The QPL-CT has potential as a simple, inexpensive intervention to aid such communication. Further investigation is needed to demonstrate the efficacy of the QPL-CT in improving cancer patient outcomes.
Practice Implications
These preliminary finding suggest that important areas of clinical trials are overlooked in clinical consultations. The QPL-CT may be an effective method to encourage oncologists to endorse patient question asking about clinical trials and prompt patient questions.
doi:10.1016/j.pec.2012.02.009
PMCID: PMC3376695  PMID: 22390854
Clinical Trials; Question Prompt Lists; Physician-patient communication
8.  Perceived risk for cancer in an urban sexual minority 
Journal of behavioral medicine  2010;34(3):157-169.
Lesbians, gay men, and bisexuals are a sexual minority experiencing elevated cancer risk factors and health disaparites, e.g., elevated tobacco use, disproportionate rates of infection with human immunodeficiency virus. Little attention has been paid to cancer prevention, education, and control in sexual minorities. This study describes cancer risk perceptions and their correlates so as to generate testable hypotheses and provide a foundation for targeting cancer prevention and risk reduction efforts in this high risk population. A cross-sectional survey of affiliates of a large urban community center serving sexual minority persons yielded a study sample of 247 anonymous persons. The survey assessed demographics, absolute perceived cancer risk, cancer risk behaviors, desired lifestyle changes to reduce cancer risk, and psychosocial variables including stress, depression, and stigma. Univariate and multivariate nonparametric statistics were used for analyses. The sample was primarily white non-Hispanic, middle-aged, and > 80% had at least a high school education. Mean values for absolute perceived cancer risk (range 0–100% risk), were 43.0 (SD = 25.4) for females, and for males, 49.3 (SD = 24.3). For females, although the multivariate regression model for absolute perceived cancer risk was statistically significant (P < .05), no single model variable was significant. For men, the multivariate regression model was significant (P < .001), with endorsement of “don't smoke/quit smoking” to reduce personal cancer risk (P < .001), and greater number of sexual partners (P = .054), positively associated with absolute perceived risk for cancer. This study provides novel data on cancer risk perceptions in sexual minorities, identifying correlates of absolute perceived cancer risk for each gender and several potential foci for cancer prevention interventions with this at-risk group.
doi:10.1007/s10865-010-9296-2
PMCID: PMC3684154  PMID: 20872174
Cancer risk perception; Cancer risk factors; Sexual minority; Health disparities
9.  Reliability of adverse symptom event reporting by clinicians 
Purpose
Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk–benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit.
Methods
A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26–91, M = 62.39) from lung (n = 134), prostate (n = 113), and Ob/Gyn (n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials.
Results
The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%).
Conclusion
Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered.
doi:10.1007/s11136-011-0031-4
PMCID: PMC3633532  PMID: 21984468
Drug toxicity; Reproducibility of results; Risk assessment; Statistical data interpretation
10.  Pilot Randomized Controlled Trial of Individual Meaning-Centered Psychotherapy for Patients With Advanced Cancer 
Journal of Clinical Oncology  2012;30(12):1304-1309.
Purpose
Spiritual well-being and sense of meaning are important concerns for clinicians who care for patients with cancer. We developed Individual Meaning-Centered Psychotherapy (IMCP) to address the need for brief interventions targeting spiritual well-being and meaning for patients with advanced cancer.
Patients and Methods
Patients with stage III or IV cancer (N = 120) were randomly assigned to seven sessions of either IMCP or therapeutic massage (TM). Patients were assessed before and after completing the intervention and 2 months postintervention. Primary outcome measures assessed spiritual well-being and quality of life; secondary outcomes included anxiety, depression, hopelessness, symptom burden, and symptom-related distress.
Results
Of the 120 participants randomly assigned, 78 (65%) completed the post-treatment assessment and 67 (56%) completed the 2-month follow-up. At the post-treatment assessment, IMCP participants demonstrated significantly greater improvement than the control condition for the primary outcomes of spiritual well-being (b = 0.39; P <.001, including both components of spiritual well-being (sense of meaning: b = 0.34; P = .003 and faith: b = 0.42; P = .03), and quality of life (b = 0.76; P = .013). Significantly greater improvements for IMCP patients were also observed for the secondary outcomes of symptom burden (b = −6.56; P < .001) and symptom-related distress (b = −0.47; P < .001) but not for anxiety, depression, or hopelessness. At the 2-month follow-up assessment, the improvements observed for the IMCP group were no longer significantly greater than those observed for the TM group.
Conclusion
IMCP has clear short-term benefits for spiritual suffering and quality of life in patients with advanced cancer. Clinicians working with patients who have advanced cancer should consider IMCP as an approach to enhance quality of life and spiritual well-being.
doi:10.1200/JCO.2011.36.2517
PMCID: PMC3646315  PMID: 22370330
11.  Validity of the Process of Change for Colorectal Cancer Screening Among African Americans 
Background
Process of change (POC) is a construct of the transtheoretical model that proposes to promote healthy behaviors.
Purpose
African Americans participate in colorectal cancer (CRC) screening less often than whites, while disease onset is younger, and incidence and mortality from CRC are higher.
Methods
POC items for CRC screening were administered to 158 African Americans, the majority of whom were female (75.9%) and were not employed (85.4%). Confirmatory factor analysis was used to validate four factors reflecting the POC sub-domains.
Results
Support of the factor validity of the POC with internal consistency of standardized alpha for the four factors was found. A logistic regression showed predictive validity in predicting current screening stage for two of the four sub-domains.
Conclusion
These data support the application of the POC to prediction of CRC screening intention among African Americans.
doi:10.1007/s12160-010-9250-0
PMCID: PMC3626411  PMID: 21165726
Transtheoretical model; Process of change; Colorectal cancer; Screening; Validity
12.  A Time-Varying Effect Model for Intensive Longitudinal Data 
Psychological Methods  2011;17(1):61-77.
Understanding temporal change in human behavior and psychological processes is a central issue in the behavioral sciences. With technological advances, intensive longitudinal data (ILD) are increasingly generated by studies of human behavior that repeatedly administer assessments over time. ILD offer unique opportunities to describe temporal behavioral changes in detail and identify related environmental and psychosocial antecedents and consequences. Traditional analytical approaches impose strong parametric assumptions about the nature of change in the relationship between time-varying covariates and outcomes of interest. This paper introduces time-varying effect models (TVEM) that explicitly model changes in the association between ILD covariates and ILD outcomes over time in a flexible manner. In this article, we describes unique research questions that the TVEM addresses, outline the model-estimation procedure, share a SAS macro for implementing the model, demonstrate model utility with a simulated example, and illustrate model applications in ILD collected as part of a smoking-cessation study to explore the relationship between smoking urges and self-efficacy during the course of the pre- and post- cessation period.
doi:10.1037/a0025814
PMCID: PMC3288551  PMID: 22103434
intensive longitudinal data; time-varying effect model; non-parametric; P-spline; applications
13.  Randomized Trial of Expressive Writing for Distressed Metastatic Breast Cancer Patients 
Psychology & health  2011;27(1):88-100.
Women with metastatic breast cancer and significant psychological distress (N = 87) were assigned randomly to engage in four home-based sessions of expressive writing or neutral writing. Women in the expressive writing group wrote about their deepest thoughts and feelings regarding their cancer, whereas women in the neutral writing group wrote about their daily activities in a factual manner. No statistically significant group differences in existential and psychological well-being, fatigue, and sleep quality were found at 8-weeks post-writing. However, the expressive writing group reported significantly greater use of mental health services during the study than the neutral writing group (55% vs. 26%, respectively; p < .05). Findings suggest that expressive writing may improve uptake of mental health services among distressed cancer patients, but is not broadly effective as a psychotherapeutic intervention.
doi:10.1080/08870446.2010.551212
PMCID: PMC3175346  PMID: 21678181
metastatic breast cancer; expressive writing; psychological distress; sleep; fatigue
14.  Poisson Growth Mixture Modeling of Intensive Longitudinal Data: An Application to Smoking Cessation Behavior 
Intensive longitudinal data (ILD) have become increasingly common in the social and behavioral sciences; count variables, such as the number of daily smoked cigarettes, are frequently-used outcomes in many ILD studies. We demonstrate a generalized extension of growth mixture modeling (GMM) to Poisson-distributed ILD for identifying qualitatively distinct trajectories in the context of developmental heterogeneity in count data. Accounting for the Poisson outcome distribution is essential for correct model identification and estimation. In addition, setting up the model in a way that is conducive to ILD measures helps with data complexities – large data volume, missing observations, and differences in sampling frequency across individuals. We present technical details of model fitting, summarize an empirical example of patterns of smoking behavior change, and describe research questions the generalized GMM helps to address.
doi:10.1080/10705511.2012.634722
PMCID: PMC3294500  PMID: 22408365
intensive longitudinal data; count data; generalized growth mixture modeling; model enumeration; smoking cessation
15.  Interpretation of Melanoma Risk Feedback in First-Degree Relatives of Melanoma Patients 
Journal of Cancer Epidemiology  2012;2012:374842.
Little is known about how individuals might interpret brief genetic risk feedback. We examined interpretation and behavioral intentions (sun protection, skin screening) in melanoma first-degree relatives (FDRs) after exposure to brief prototypic melanoma risk feedback. Using a 3 by 2 experimental pre-post design where feedback type (high-risk mutation, gene environment, and nongenetic) and risk level (positive versus negative findings) were systematically varied, 139 melanoma FDRs were randomized to receive one of the six scenarios. All scenarios included an explicit reminder that melanoma family history increased their risk regardless of their feedback. The findings indicate main effects by risk level but not feedback type; positive findings led to heightened anticipated melanoma risk perceptions and anticipated behavioral intentions. Yet those who received negative findings often discounted their family melanoma history. As such, 25%, 30%, and 32% of those who received negative mutation, gene-environment, and nongenetic feedback, respectively, reported that their risk was similar to the general population. Given the frequency with which those who pursue genetic testing may receive negative feedback, attention is needed to identify ideal strategies to present negative genetic findings in contexts such as direct to consumer channels where extensive genetic counseling is not required.
doi:10.1155/2012/374842
PMCID: PMC3410311  PMID: 22888347
16.  Exposure to and Intention to Discuss Cancer-Related Internet Information Among Patients With Breast Cancer 
Journal of Oncology Practice  2011;8(1):40-45.
An assessment of the frequency with which patients with breast cancer attend physician visits having recently read and intending to discuss cancer-related information from the Internet.
Purpose:
Previous studies have reported a significant number of patients with breast cancer seek cancer-related information from the Internet. Most studies have asked whether a patient has ever read Internet information since her diagnosis. The purpose of this study was to assess the frequency with which patients with breast cancer come to physician appointments having recently read and intending to discuss cancer-related information from the Internet.
Patients and Methods:
We asked 558 patients with breast cancer who were waiting to see their physicians about their experiences reading cancer-related information from the Internet and their intent to discuss the information in their current visit.
Results:
Fifteen percent reported reading cancer-related Internet information in the past month. Patients who had read such information in the past month were younger, had been diagnosed more recently, and were more likely to be attending a new visit. Of those who had read in the past month, 45% reported intending to discuss what they had read with their physician. Nineteen percent of patients reported having ever read breast cancer–related Internet information since their diagnosis.
Conclusion:
The proportion of patients with breast cancer planning to discuss Internet information during their current physician visit was relatively small. Few characteristics were associated with recent Internet use or intent to discuss.
doi:10.1200/JOP.2011.000271
PMCID: PMC3266315  PMID: 22548010
17.  Using Confirmatory Factor Analysis to Evaluate Construct Validity of the Brief Pain Inventory (BPI) 
Context
The Brief Pain Inventory (BPI) is a frequently used instrument designed to assess the patient-reported outcome of pain. The majority of factor analytic studies have found a two-factor (i.e., pain intensity and pain interference) structure for this instrument; however, since the BPI was developed with an a priori hypothesis of the relationship among its items, it follows that construct validity investigations should utilize confirmatory factor analysis (CFA).
Objectives
The purpose of this work is to establish the construct validity of the BPI using a CFA framework and demonstrate factorial invariance using a range of demographic variables.
Methods
A retrospective CFA was completed in a sample of individuals diagnosed with HIV/AIDS and cancer (n = 364; 63% male; age 21-92 years, M = 51.80). A baseline one-factor model was compared against two-factor and three-factor models (i.e., pain intensity, activity interference, and affective interference) that were developed based on the hypothetical design of the instrument.
Results
Fit indices for the three-factor model were statistically superior when compared to the one-factor model and marginally better in comparison to the two-factor model. This three-factor structure was found to be invariant across disease, age, and ethnicity groups.
Conclusion
The results of this study provide evidence to support a three-factor representation of the BPI, as well as the originally hypothesized two-factor structure. Such findings will begin to provide clinical trialists, pharmaceutical sponsors, and regulators with confidence in the psychometric properties of this instrument when considering its inclusion in clinical research.
doi:10.1016/j.jpainsymman.2010.05.008
PMCID: PMC3062715  PMID: 21131166
Factor analysis; psychometrics; pain; reproducibility of results; affective symptoms
18.  Longitudinal Assessment of Cognitive Changes Associated With Adjuvant Treatment for Breast Cancer: Impact of Age and Cognitive Reserve 
Journal of Clinical Oncology  2010;28(29):4434-4440.
Purpose
To examine the impact of age and cognitive reserve on cognitive functioning in patients with breast cancer who are receiving adjuvant treatments.
Patients and Methods
Patients with breast cancer exposed to chemotherapy (n = 60; mean age, 51.7 years) were evaluated with a battery of neuropsychological and psychological tests before treatment and at 1, 6, and 18 months after treatment. Patients not exposed to chemotherapy (n = 72; mean age, 56.6 years) and healthy controls (n = 45; mean age, 52.9 years) were assessed at matched intervals.
Results
Mixed-effects modeling revealed significant effects for the Processing Speed and Verbal Ability domains. For Processing Speed, a three-way interaction among treatment group, age, and baseline cognitive reserve (P < .001) revealed that older patients with lower baseline cognitive reserve who were exposed to chemotherapy had lower performance on Processing Speed compared with patients not exposed to chemotherapy (P = .003) and controls (P < .001). A significant group by time interaction for Verbal Ability (P = .01) suggested that the healthy controls and no chemotherapy groups improved over time. The chemotherapy group failed to improve at 1 month after treatment but improved during the last two follow-up assessments. Exploratory analyses suggested a negative effect of tamoxifen on Processing Speed (P = .036) and Verbal Memory (P = .05) in the no-chemotherapy group.
Conclusion
These data demonstrated that age and pretreatment cognitive reserve were related to post-treatment decline in Processing Speed in women exposed to chemotherapy and that chemotherapy had a short-term impact on Verbal Ability. Exploratory analysis of the impact of tamoxifen suggests that this pattern of results may be due to a combination of chemotherapy and tamoxifen.
doi:10.1200/JCO.2009.27.0827
PMCID: PMC2988635  PMID: 20837957
19.  Visual P2-N2 complex and arousal at the time of encoding predict the time domain characteristics of amnesia for multiple intravenous anesthetic drugs in humans 
Anesthesiology  2010;113(2):313-326.
Background
Intravenous anesthetics have marked effects on memory function, even at subclinical concentrations. Fundamental questions remain in characterizing anesthetic amnesia and identifying affected systems-level processes. We applied a mathematical model to evaluate time-domain components of anesthetic amnesia in human subjects.
Methods
61 volunteers were randomized to receive propofol (n = 12), thiopental (13), midazolam (12), dexmedetomidine (12), or placebo (12). With drug present, subjects encoded pictures into memory using a 375-item continuous recognition task, with subsequent recognition later probed with drug absent. Memory function was sampled at up to 163 time points, and modeled over the time domain using a two-parameter, first-order negative power function. The parietal event-related P2-N2 complex was derived from electroencephalography, and arousal repeatedly sampled. Each drug was evaluated at two concentrations.
Results
The negative power function consistently described the course of amnesia (mean R2 = 0.854), but there were marked differences between drugs in the modulation of individual components (P < 0.0001). Initial memory strength was a function of arousal (P = 0.005), while subsequent decay was related to reaction time (P < 0.0001) and the P2-N2 complex (P = 0.007/0.002 for discrete components).
Conclusions
In humans, the amnesia caused by multiple intravenous anesthetic drugs is characterized by arousal-related effects on initial trace strength, and a subsequent decay predicted by attenuation of the P2-N2 complex at encoding. We propose that failure of normal memory consolidation follows drug-induced disruption of interregional synchrony critical for neuronal plasticity, and discuss our findings in the framework of memory systems theory.
doi:10.1097/ALN.0b013e3181dfd401
PMCID: PMC2910207  PMID: 20613477
20.  Classification and Regression Tree Uncovered Hierarchy of Psychosocial Determinants Underlying Quality Of Life Response Shift in HIV/AIDS 
Journal of clinical epidemiology  2009;62(11):1138-1147.
Objectives
Rapkin and Schwartz [1] define response shift as otherwise unexplained, discrepant change in HRQOL that is associated with change in cognitive appraisal. In this paper, we demonstrate how a Recursive Partitioning (RPART) regression tree analytic approach may be used to explore cognitive changes to gain additional insight into response shift phenomena.
Study Design and Setting
Data are from the “Choices in Care Study,” [2], an evaluation of HIV+ Medicaid recipients’ experiences and outcomes in care (N = 394). Cognitive assessment was based on the Quality of Life Appraisal Battery. HRQOL was measured by the MOS-SF36v2 [3].
Results
We used RPART to examine six-month change in MOS mental composite as a function of changes in appraisal, after controlling for patient characteristics, health changes and intervening events. RPART identified nine distinct patterns of cognitive change, including three associated with negative discrepancies, four with positive discrepancies, and two with no discrepancies.
Conclusion
RPART classification provides a nuanced treatment of response shift. This methodology has implications for evaluating programs, guiding decisions and targeting care.
doi:10.1016/j.jclinepi.2009.03.021
PMCID: PMC2754600  PMID: 19595576
response shift; health related quality of life; classification and regression trees
21.  Barriers to Mental Health Service Use among Hematopoietic Stem Cell Transplant Survivors 
Bone marrow transplantation  2009;45(3):570-579.
Summary
This study examined barriers to mental health service use and their demographic, medical, and psychosocial correlates among hematopoietic stem cell transplant (HSCT) survivors. A sample of 253 HSCT survivors who were 1- to 3-years post-transplant completed measures of demographic, physical, psychological, and social characteristics as well as a newly modified measure of barriers to mental health service use. Only 50% of distressed HSCT survivors had received mental health services. An exploratory factor analysis of the barriers to mental health service use scale yielded four factors: Scheduling Barriers, Knowledge Barriers, Emotional Barriers, and Illness-related Barriers. Patients with higher social constraints (perceived problems discussing the illness experience with significant others) reported higher levels of all four types of barriers. General distress and transplant-related posttraumatic stress symptoms were positively associated with emotional, knowledge, and illness-related barriers to mental health service use, whereas physical and functional well-being were inversely associated with these barriers. Having more knowledge barriers and more emotional barriers predicted a lower likelihood of receiving mental health services, as did lower levels of education and general distress. Results suggest that a significant number of HSCT survivors may benefit from education about mental health services that is tailored to individual barriers.
doi:10.1038/bmt.2009.166
PMCID: PMC2866642  PMID: 19597417
hematopoietic stem cell transplantation; cancer survivorship; barriers; mental health services; psychological
22.  Propofol and midazolam inhibit conscious memory processes very soon after encoding: An event related potential study of familiarity and recollection in volunteers 
Anesthesiology  2009;110(2):295-312.
Background
Intravenous drugs active via gamma-aminobutyric acid receptors produce memory impairment during conscious sedation. Memory function was assessed using event related potentials (ERPs) while drug was present.
Methods
The continuous recognition task measured recognition of photographs from working (6 seconds) and long term (27 seconds) memory while ERPs were recorded from Cz (familiarity recognition) and Pz electrodes (recollection recognition). Volunteer participants received sequential doses of one of placebo (n=11), propofol 0.45 and 0.9 ug/ml (n=10), midazolam 20 and 40 ng/ml (n=12), thiopental 1.5 and 3 ug/ml (n=11), or dexmedetomidine 0.25 and 0.4 ng/ml (n=11). End of day yes/no recognition 225 minutes after the end of drug infusion tested memory retention of pictures encoded on the continuous recognition tasks.
Results
Active drugs increased reaction times and impaired memory on the continuous recognition task equally, except for a greater effect of midazolam (p<0.04). Forgetting from continuous recognition tasks to end of day was similar for all drugs (p=0.40), greater than placebo (p<0.001). Propofol and midazolam decreased the area between first presentation (new) and recognized (old, 27 seconds later) ERP waveforms from long term memory for familiarity (p=0.03) and possibly for recollection processes (p=0.12). Propofol shifted ERP amplitudes to smaller voltages (p<0.002). Dexmedetomidine may have impaired familiarity more than recollection processes (p=0.10). Thiopental had no effect on ERPs.
Conclusion
Propofol and midazolam impaired recognition ERPs from long term, but not working memory. ERP measures of memory revealed different pathways to end of day memory loss as early as 27 seconds after encoding.
doi:10.1097/ALN.0b013e3181942ef0
PMCID: PMC2735240  PMID: 19194157
23.  Staff Engagement During Complex Pediatric Medical Care: The Role of Patient, Family, and Treatment Variables 
Objective
To examine the role of patient, family, and treatment variables on self-reported engagement for physicians and nurses working with pediatric complex care patients.
Methods
Sixty-eight physicians and 85 registered nurses at a children’s hospital reviewed eight case scenarios that varied by the patient and patient’s family (each cooperative vs. difficult) and the length of hospitalization (<30 vs. >30 days). Participants rated their engagement from highly engaged/responsive to distancing/disconnected behaviors.
Results
Nurses were more likely than physicians to engage in situations with a difficult patient/cooperative family but less likely to engage in situations with a cooperative patient/difficult family. Nurses were more likely to consult a colleague regarding the care of a difficult patient/difficult family, while physicians were more likely to refer a difficult patient/difficult family to a psychosocial professional.
Conclusions
Differences were found for engagement with “difficult” patients/families, with physicians more likely to distance themselves or refer to a psychosocial professional, while nurses were more likely to consult with a colleague.
Practice Implications
Communication between health care team members is essential for optimal family centered health care. Thus, interventions are needed that focus on communication and support for health care teams working with pediatric complex care patients and their families.
doi:10.1016/j.pec.2008.07.051
PMCID: PMC2775508  PMID: 19209401
complex care patients; difficult patients; communication; staff engagement
24.  Men's values-based factors on prostate cancer risk genetic testing: A telephone survey 
BMC Medical Genetics  2004;5:28.
Background
While a definitive genetic test for Hereditary Prostate Cancer (HPC) is not yet available, future HPC risk testing may become available. Past survey data have shown high interest in HPC testing, but without an in-depth analysis of its underlying rationale to those considering it.
Methods
Telephone computer-assisted interviews of 400 men were conducted in a large metropolitan East-coast city, with subsequent development of psychometric scales and their correlation with intention to receive testing.
Results
Approximately 82% of men interviewed expressed that they "probably" or "definitely" would get genetic testing for prostate cancer risk if offered now. Factor analysis revealed four distinct, meaningful factors for intention to receive genetic testing for prostate cancer risk. These factors reflected attitudes toward testing and were labeled "motivation to get testing," "consequences and actions after knowing the test result," "psychological distress," and "beliefs of favorable outcomes if tested" (α = 0.89, 0.73, 0.73, and 0.60, respectively). These factors accounted for 70% of the total variability. The domains of motivation (directly), consequences (inversely), distress (inversely), and positive expectations (directly) all correlated with intention to receive genetic testing (p < 0.001).
Conclusions
Men have strong attitudes favoring genetic testing for prostate cancer risk. The factors most associated with testing intention include those noted in past cancer genetics studies, and also highlights the relevance in considering one's motivation and perception of positive outcomes in genetic decision-making.
doi:10.1186/1471-2350-5-28
PMCID: PMC544862  PMID: 15588314
25.  Community asthma education program for parents of urban asthmatic children. 
OBJECTIVES: To demonstrate the effectiveness of community asthma education provided by peers in the urban community. METHOD: A convenience sample of 267 self-referred, primarily African-American parents or primary caregivers of asthmatic children aged 18 months to 16 years completed a five-session education program. Program efficacy was evaluated at baseline, immediately postinstruction, and at three-, six-, and 12 months retention. Outcomes included three questionnaires measuring asthma self-management knowledge, control and quality of life. RESULTS: Immediately following program completion, participants demonstrated improvements in asthma knowledge (13% increased proportion correct, p < 0.01), ability to control their child's asthma 16% increased score, p < 0.01), and asthma quality of life (7% increased score, p < 0.01). Retention of knowledge with steady improvement of control and quality of life was observed up to one year postinstruction, as compared with immediate postprogram scores (p = 0.09 and 0.05, respectively). CONCLUSIONS: A community-based asthma educational program for caregivers should be an important component of childhood asthma management. The complexities of asthma management are best taught in educational programs that are easily accessible, provide a comfortable environment for participants, and are taught by peers.
PMCID: PMC2568435  PMID: 15253327

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