Publications

BACKGROUND

The high prevalence of limited health literacy among patients threatens the success of secure electronic messaging between patients from diverse populations and their providers.

OBJECTIVE

The purpose of this study is to generate hypotheses about the readability of patient and provider electronic messages.

METHODS

We collected 31 patient-provider e-mail exchanges (n = 119 total messages) from a safety-net primary care clinic. We compared the messages' mean word count and Flesch-Kincaid Grade Levels (FKGLs), calculated the frequency of provider messages below an FKGL = 8, and assessed readability concordance between patients' and providers' messages.

RESULTS

Patients used more words in their initial e-mails compared to providers, but the FKGLs were similar, and 68% of provider messages were written below an FKGL = 8. Of 31 exchanges, 9 (29%) contained at least one patient message with an FKGL > 3 grade levels lower than the corresponding provider message(s).

CONCLUSION

Our study demonstrates that most providers are able to respond to patient electronic messages with a matching reading level.

OBJECTIVE

To assess the perspectives of women with lupus nephritis on barriers to medication decision making.

METHODS

We used the nominal group technique (NGT), a structured process to elicit ideas from participants, for a formative assessment. Eight NGT meetings were conducted in English and moderated by an expert NGT researcher at 2 medical centers. Participants responded to the question: "What sorts of things make it hard for people to decide to take the medicines that doctors prescribe for treating their lupus kidney disease?" Patients nominated, discussed, and prioritized barriers to decisional processes involving medications for treating lupus nephritis.

RESULTS

Fifty-one women with lupus nephritis with a mean age of 40.6 ± 13.3 years and disease duration of 11.8 ± 8.3 years participated in 8 NGT meetings: 26 African Americans (4 panels), 13 Hispanics (2 panels), and 12 whites (2 panels). Of the participants, 36.5% had obtained at least a college degree and 55.8% needed some help in reading health materials. Of the 248 responses generated (range 19-37 responses/panel), 100 responses (40%) were perceived by patients as having relatively greater importance than other barriers in their own decision-making processes. The most salient perceived barriers, as indicated by percent-weighted votes assigned, were known/anticipated side effects (15.6%), medication expense/ability to afford medications (8.2%), and the fear that the medication could cause other diseases (7.8%).

CONCLUSION

Women with lupus nephritis identified specific barriers to decisions related to medications. Information relevant to known/anticipated medication side effects and medication cost will form the basis of a patient guide for women with systemic lupus erythematosus, currently under development.

PURPOSE

Little is known about the prevalence of combined anxiety and depressive symptoms (CADS) in breast cancer patients. Purpose was to evaluate for differences in demographic and clinical characteristics and quality of life (QOL) prior to breast cancer surgery among women classified into one of four distinct anxiety and/or depressive symptom groups.

METHODS

A total of 335 patients completed measures of anxiety and depressive symptoms and QOL prior to and for 6 months following breast cancer surgery. Growth Mixture Modelling (GMM) was used to identify subgroups of women with distinct trajectories of anxiety and depressive symptoms. These results were used to create four distinct anxiety and/or depressive symptom groups. Differences in demographic, clinical, and symptom characteristics, among these groups were evaluated using analyses of variance and Chi square analyses.

RESULTS

A total of 44.5% of patients were categorized with CADS. Women with CADS were younger, non-white, had lower performance status, received neoadjuvant or adjuvant chemotherapy, had greater difficulty dealing with their disease and treatment, and reported less support from others to meet their needs. These women had lower physical, psychological, social well-being, and total QOL scores. Higher levels of anxiety with or without subsyndromal depressive symptoms were associated with increased fears of recurrence, hopelessness, uncertainty, loss of control, and a decrease in life satisfaction.

CONCLUSIONS

Findings suggest that CADS occurs in a high percentage of women following breast cancer surgery and results in a poorer QOL. Assessments of anxiety and depressive symptoms are warranted prior to surgery for breast cancer.

BACKGROUND

The mammalian target of rapamycin (mTOR) pathway is essential for tumor development, yet mTOR inhibitors have yielded modest results. This phase 1 study investigated the mTORC1/mTORC2 inhibitor CC-223 in patients with advanced cancer.

METHODS

Patients with advanced solid tumors or multiple myeloma received an initial dose of 7.5-60 mg of CC-223, followed by oral daily dosing in 28-day cycles until disease progression. The primary objective was to determine the safety, tolerability, nontolerated dosage, maximum tolerated dosage (MTD), and preliminary pharmacokinetic profile. Secondary objectives were to evaluate pharmacodynamic effects and to describe preliminary efficacy.

RESULTS

Twenty-eight patients were enrolled and received ≥1 dose of CC-223. The most common treatment-related grade 3 adverse events were hyperglycemia, fatigue, and rash. Four patients had dose-limiting toxicities, including hyperglycemia, rash, fatigue, and mucositis. Therefore, 45 mg/d was determined to be the MTD. The pharmacokinetics of CC-223 demonstrated a mean terminal half-life ranging from 4.86 to 5.64 hours and maximum observed plasma concentration ranging from 269 to 480 ng/mL in patients who received CC-223 ≥45 mg/d. Phosphorylation of mTORC1/mTORC2 pathway biomarkers in blood cells was inhibited by CC-223 ≥30 mg/d with an exposure-response relationship. Best responses included 1 partial response (breast cancer; response duration 220 days; 30-mg/d cohort), stable disease (8 patients across ≥15 mg/d cohorts; response duration range, 36-168 days), and progressive disease (12 patients). The disease control rate was 32%.

CONCLUSIONS

CC-223 was tolerable, with manageable toxicities. Preliminary antitumor activity, including tumor regression, and evidence of mTORC1/mTORC2 pathway inhibition were observed.