Publications

OBJECTIVE

To evaluate whether low ratings of interactions with providers and health plans in 2013 were associated with increased systemic lupus erythematosus (SLE) damage in 2015.

METHODS

Data were derived from the Lupus Outcomes Study (LOS) annual surveys and include items from the Consumer Assessment of Health Plans and Interpersonal Processes of Care Scale measuring dimensions of health care interactions. We used ordinary least squares regression to model the change in disease damage over a 2-year period, 2013-2015, as a function of ratings of multiple dimensions of interactions with providers and health plans, with and without adjustment for demographic characteristics, socioeconomic status, and SLE and overall health status, and logistic regression to estimate the effect of the same matrix of variables on the probability of experiencing a minimum clinically important increase in damage.

RESULTS

There were 566 LOS respondents who were followed from 2013-2015 and who rated their providers and health plans in 2013. After adjustment, persons with SLE rating their providers poorly in patient-provider communication experienced a significantly greater accrual of disease damage (odds ratio [OR] 0.23 [95% confidence interval (95% CI) 0.09-0.38]) and were more likely to experience a minimum clinically important increase in damage (OR 2.35 [95% CI 1.25-4.39]). After adjustment, those rating their health plan poorly on care coordination experienced a significantly greater accrual of disease damage (OR 0.19 [95% CI 0.03-0.35]) and were more likely to experience a minimum clinically important increase in damage (OR 2.20 [95% CI 1.12-4.34]).

CONCLUSION

Poor patient-provider communication and care coordination may result in increased disease damage.

PURPOSE

Discussions between oncologists and advanced cancer patients (ACPs) may touch on the complex issue of clinical trial participation. Numerous initiatives have sought to improve the quality of these potentially difficult conversations. However, we have limited data about what ACPs know about clinical research as they enter such discussions as, to date, such research has focused on the period following informed consent. This study examines ACPs' understanding of clinical research in the treatment period before consent.

METHODS

We conducted in-depth interviews with adult ACPs with limited treatment options at four clinics in an academic medical center. So as not to influence patients' perspectives, interviewers probed patients' knowledge of clinical research only if the patient first brought up the topic. Interviews (40-60 min) were audio-recorded, transcribed, and analyzed thematically and via quantitative content analysis by an interdisciplinary team.

RESULTS

Of 78 patients recruited, 56 (72%) spontaneously brought up the topic of clinical research during interview and are included in this analysis. Qualitative thematic analysis and quantitative content analysis revealed that patients' knowledge varied in terms of (1) accuracy and (2) specificity (level of detail). ACPs who spoke with high specificity were not always accurate, and ACPs with accurate knowledge included both high- and low-specificity speakers.

CONCLUSIONS

ACPs' knowledge of clinical research is variable. Patients who can discuss the technical details of their care may or may not understand the broader purpose and procedures of clinical trials. Understanding this variability is important for improving patient-provider communication about clinical research and supporting efforts to provide individualized care for ACPs.

INTRODUCTION

Lesbian, gay, and bisexual (LGB) individuals smoke at rates 1.5-2 times higher than the general population, but less is known about LGB consumption of other tobacco products (OTPs) and gender differences. OTP use among young adult LGB bar patrons and the relationship among past quit attempts, intention to quit, and binge drinking with OTP use was examined.

METHODS

A cross-sectional survey of young adults (aged 18-26) in bars/nightclubs in seven U.S. cities between 2012 and 2014 (N=8,010; 1,101 LGB participants) was analyzed in 2016. Logistic regressions examined current use of five OTPs (cigarillos, electronic cigarettes, hookah, chewing tobacco, and snus) and sexual minority status, adjusting for demographics and comparing LB women and GB men with their heterosexual counterparts.

RESULTS

LGB bar/nightclub patrons used all OTPs more than their heterosexual counterparts. LB women were more likely than heterosexual women to use cigarillos, electronic cigarettes, hookah, chew, and snus. GB men were more likely than heterosexual men to smoke cigarillos, electronic cigarettes, hookah, and use chew and snus. Past-year quit attempt was associated with increased odds of electronic cigarette use in men and women, and increased odds of dual use (cigarettes and OTPs) among men. Intention to quit was negatively associated with dual use among women. Binge drinking was associated with increased use of all OTPs across genders.

CONCLUSIONS

LGB bar-going young adults are at higher risk for OTP use than their heterosexual counterparts. Bar-based interventions are needed to address all forms of tobacco use in this high-risk group.

This phase 1b, open-label, dose-escalation study assessed the safety, efficacy, and pharmacokinetics of anti-CD38 monoclonal antibody isatuximab given in 2 schedules (3, 5, or 10 mg/kg every other week [Q2W] or 10 or 20 mg/kg weekly [QW] for 4 weeks and then Q2W thereafter [QW/Q2W]), in combination with lenalidomide 25 mg (days 1-21) and dexamethasone 40 mg (QW), in patients with relapsed/refractory multiple myeloma (RRMM). Patients received 28-day treatment cycles; the primary objective was to determine the maximum tolerated dose (MTD) of isatuximab with lenalidomide and dexamethasone. Fifty-seven patients (median 5 [range 1-12] prior regimens; 83% refractory to previous lenalidomide therapy) were treated. Median duration of dosing was 36.4 weeks; 15 patients remained on treatment at data cutoff. Isatuximab-lenalidomide-dexamethasone was generally well tolerated with only 1 dose-limiting toxicity reported (grade 3 pneumonia at 20 mg/kg QW/Q2W); the MTD was not reached. The most common isatuximab-related adverse events were infusion-associated reactions (IARs) (56%), which were grade 1/2 in 84% of patients who had an IAR and predominantly occurred during the first infusion. In the efficacy-evaluable population, the overall response rate (ORR) was 56% (29/52) and was similar between the 10 mg/kg Q2W and 10 and 20 mg/kg QW/Q2W cohorts. The ORR was 52% in 42 evaluable lenalidomide-refractory patients. Overall median progression-free survival was 8.5 months. Isatuximab exposure increased in a greater than dose-proportional manner; isatuximab and lenalidomide pharmacokinetic parameters appeared independent. These data suggest that isatuximab combined with lenalidomide and dexamethasone is active and tolerated in heavily pretreated patients with RRMM. This trial was registered at www.clinicaltrials.gov as #NCT01749969.

BACKGROUND

Despite their well-recognised shortcomings, haemodialysis catheters (HDCs) remain an important form of haemodialysis access for many patients. There are several HDCs commercially available, each differing considerably in design, which is known to significantly influence performance and survival. We sought to determine which of two tunnelled HDCs, DuraMax® (Angiodynamics, NY, USA) or SplitCath® (MedComp, PA, USA) delivers the best performance, safety and reliability for dialysis patients.

METHODS

Eighty-six patients were prospectively randomised to receive either DuraMax® (DM) or SplitCath® (SC). Outcomes included: (i) mean flow rates (mL/min) averaged over the first 10 weeks of dialysis, and urea reduction ratio (URR); and (ii) long-term catheter survival with appraisal of any events leading to catheter dysfunction and early removal.

RESULTS

Median flow rates (interquartile range) in the DM and SC groups were 321 (309-343) and 309 (294-322) mL/min, respectively (p = 0.002). URR values for the DM and SC groups were 71 (65-76) and 74 (70-78), respectively, (p = 0.094). There was no significant difference in long-term survival or frequency of incidents that required early HDC removal (9/43 in the DM group, 5/43 patients SC). A slightly higher incidence of HDC dislodgement was noted in the DM group, although this study was not statistically powered to determine its significance.

CONCLUSIONS

We conclude that DM yields slightly higher flow rates in the first 10 weeks of dialysis, and a similar low incidence of complications and long-term survival for both DM and SC HDCs.