Browsing by Author "Williams, David A."

Now showing 1 - 5 of 5
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    If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program
    (Oxford University Press, 2022) Reuman, Lillian; Solar, Chelsey; MacLean, R. Ross; Halat, Allison M.; Rajeevan, Haseena; Williams, David A.; Heapy, Alicia A.; Bair, Matthew J.; Krein, Sarah L.; Kerns, Robert D.; Higgins, Diana M.; Medicine, School of Medicine
    Little is known about how individuals with chronic pain use tailored internet-based interventions. This study is the first to compare self-reported skill module use to observed module access and to examine each of these in relationship to tailored recommendations to access specific content. Participants (N = 58) enrolled in a 10-week trial of the Pain EASE program, a tailored internet-based intervention that includes 10 pain self-management skill modules. Participants completed a “Self-Assessment,” which was used to provide a “Personalized Plan” that encouraged accessing specific modules. Participants self-reported module use during weekly data collection telephone calls. Program log data were extracted to capture “observed” module use during the trial period. Findings indicated significantly greater self-reported use of the Pain EASE modules compared to observed access with log data. Further, log data revealed that participants accessed less than half of the modules recommended to them via tailoring.
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    Patient-reported symptoms and discontinuation of adjuvant aromatase inhibitor therapy
    (Wiley, 2014-08-15) Kidwell, Kelley M.; Harte, Steven E.; Hayes, Daniel F.; Storniolo, Anna Maria; Carpenter, Janet; Flockhart, David A.; Stearns, Vered; Clauw, Daniel J.; Williams, David A.; Henry, N. Lynn; Department of Medicine, IU School of Medicine
    BACKGROUND: Aromatase inhibitor (AI) therapy results in substantial survival benefits for patients with hormone receptor-positive breast cancer. The rates of poor adherence and discontinuation of AI therapy are high, primarily because of treatment-related toxicities like musculoskeletal pain. Although pain-related symptoms may worsen during AI therapy, the authors hypothesized that nonpersistence with AI therapy was associated with symptoms that were present before treatment initiation. METHODS: Postmenopausal women initiating AI therapy who were enrolled in a prospective clinical trial completed questionnaires at baseline to assess sleep, fatigue, mood, and pain. Reasons for treatment discontinuation during the first year of treatment were recorded. Associations between baseline patient-reported symptoms and treatment discontinuation because of toxicity were identified using logistic regression. RESULTS: Four hundred forty-nine patients were evaluable. The odds of treatment discontinuation were higher in patients who reported a greater number of symptoms before AI initiation. Baseline poor sleep quality was associated with early treatment discontinuation, with an odds ratio (OR) of 1.91 (95% confidence interval [CI], 1.26-2.89; P = .002). Baseline presence of tired feeling and forgetfulness had similar ORs for discontinuation (tired feeling: OR, 1.76; 95% CI, 1.15-2.67; P = .009; forgetfulness: OR, 1.66; 95% CI, 1.11-2.48; P = .015). An increasing total number of baseline symptoms was associated with an increased likelihood of treatment discontinuation, with an OR of 1.89 (95% CI, 1.20-2.96; P = .006) for 3 to 5 symptoms versus 0 to 2 symptoms. CONCLUSIONS: Symptom clusters in breast cancer survivors that are present before the initiation of adjuvant AI therapy may have a negative impact on a patient's persistence with therapy. Interventions to manage these symptoms may improve breast cancer outcomes and quality of life.
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    Predictors of engagement in an internet-based cognitive behavioral therapy program for veterans with chronic low back pain
    (Oxford University Press, 2021) Solar, Chelsey; Halat, Allison M.; MacLean, R. Ross; Rajeevan, Haseena; Williams, David A.; Krein, Sarah L.; Heapy, Alicia A.; Bair, Matthew J.; Kerns, Robert D.; Higgins, Diana M.; Medicine, School of Medicine
    Internet-based interventions for chronic pain have demonstrated efficacy and may address access barriers to care. Participant characteristics have been shown to affect engagement with these programs; however, limited information is available about the relationship between participant characteristics and engagement with internet-based programs for self-management of chronic pain. The current study examined relationships between demographic and clinical characteristics and engagement with the Pain EASE program, a self-directed, internet-based cognitive behavioral therapy intervention for veterans with chronic low back pain (cLBP). Veterans with cLBP were enrolled in a 10 week trial of the Pain EASE program. Engagement measures included the number of logins, access to coping skill modules, and completed study staff-initiated weekly check-in calls. Regression analyses were conducted to identify significant predictors of engagement from hypothesized predictors (e.g., race/ethnicity, age, depressive symptom severity, and pain interference). Participants (N = 58) were 93% male, 60.3% identified as White, and had a mean age of 54.5 years. Participants logged into the program a median of 3.5 times, accessed a median of 2 skill modules, and attended a median of 6 check-in calls. Quantile regression revealed that, at the 50th percentile, non-White-identified participants accessed fewer modules than White-identified participants (p = .019). Increased age was associated with increased module use (p = .001). No clinical characteristics were significantly associated with engagement measures. White-identified race/ethnicity and increased age were associated with greater engagement with the Pain EASE program. Results highlight the importance of defining and increasing engagement in internet-delivered pain care.
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    Real-Time PCR: An Effective Tool for Measuring Transduction Efficiency in Human Hematopoietic Progenitor Cells
    (Elsevier, 2004-12-04) Villella, Anthony D.; Yao, Jing; Getty, Robert R.; Juliar, Beth E.; Yiannoutsos, Constantin; Hartwell, Jennifer R.; Cai, Shanbao; Sadat, Mohammed A.; Cornetta, Kenneth; Williams, David A.; Pollok, Karen E.; Medical and Molecular Genetics, School of Medicine
    Accurate measurement of gene transfer into hematopoietic progenitor cells is an essential prerequisite for assessing the utility of gene therapy approaches designed to correct hematologic defects. We developed a reliable method to measure transduction efficiency at the level of the progenitor cell with real-time polymerase chain reaction (PCR) analysis of individual progenitor-derived colonies. We hypothesized that this method would demonstrate better sensitivity and specificity than are currently achievable with conventional PCR. An oncoretroviral vector containing the enhanced green fluorescent protein was used to transduce human CD34+ cells derived from bone marrow or granulocyte-colony-stimulating factor-mobilized peripheral blood. Progenitor assays were set up and colonies plucked after visualization by fluorescence microscopy. By analyzing microscopically identified fluorescent samples and nontransduced samples, we calculated an overall sensitivity and specificity of 90.2 and 95.0%, respectively. Real-time PCR had higher specificity and sensitivity than conventional PCR as analyzed by generalized linear models (P = 0.002 and P = 0.019, respectively). In conclusion, we found real-time PCR to have superior sensitivity and specificity compared to conventional PCR in determining transduction efficiency of hematopoietic progenitor cells.
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    Replication competent retrovirus testing (RCR) in the National Gene Vector Biorepository: No evidence of RCR in 1,595 post-treatment peripheral blood samples obtained from 60 clinical trials
    (Elsevier, 2023) Cornetta, Kenneth; Yao, Jing; House, Kimberley; Duffy, Lisa; Adusumilli, Prasad S.; Beyer, Rachel; Booth, Claire; Brenner, Malcolm; Curran, Kevin; Grilley, Bambi; Heslop, Helen; Hinrichs, Christian S.; Kaplan, Rosandra N.; Kiem, Hans-Peter; Kochenderfer, James; Kohn, Donald B.; Mailankody, Sham; Norberg, Scott M.; O’Cearbhaill, Roisin E.; Pappas, Jennifer; Park, Jae; Ramos, Carlos; Ribas, Antonio; Rivière, Isabelle; Rosenberg, Steven A.; Sauter, Craig; Shah, Nirali N.; Slovin, Susan F.; Thrasher, Adrian; Williams, David A.; Lin, Tsai-Yu; Medical and Molecular Genetics, School of Medicine
    The clinical impact of any therapy requires the product be safe and effective. Gammaretroviral vectors pose several unique risks, including inadvertent exposure to replication competent retrovirus (RCR) that can arise during vector manufacture. The US FDA has required patient monitoring for RCR, and the National Gene Vector Biorepository is an NIH resource that has assisted eligible investigators in meeting this requirement. To date, we have found no evidence of RCR in 338 pre-treatment and 1,595 post-treatment blood samples from 737 patients associated with 60 clinical trials. Most samples (75%) were obtained within 1 year of treatment, and samples as far out as 9 years after treatment were analyzed. The majority of trials (93%) were cancer immunotherapy, and 90% of the trials used vector products produced with the PG13 packaging cell line. The data presented here provide further evidence that current manufacturing methods generate RCR-free products and support the overall safety profile of retroviral gene therapy.