ERT (Germany)

<b>Background:</b> Electronic patient-reported outcomes (ePROs) are a reliable method for collecting data in clinical trials and offer many advantages over paper collection. It is essential to consider patient preference and ease of use when employing this technology. Improving the usability of ePRO in COPD clinical trials could reduce subject burden and improve engagement. <b>Methods:</b> 103 subjects with chronic obstructive pulmonary disease (COPD) were surveyed regarding their preferences for ePRO display. <b>Results:</b> Subjects thought that underlining (33%) and capitalization (33%) best drew attention to emphasized words on an ePRO screen. Subjects saw screens of a multi-select question displayed to the left of or above the answer options. 46% could read and understand the screens equally; of those with a preference, 63% preferred the top to bottom format. Subjects saw screens of a tablet ePRO device with one question per screen or several questions per screen. 54% preferred one question per screen because it was easier to read (66%) and easier to understand the question (41%). 46% preferred multiple questions per screen because it was easier to read (51%) and faster to complete (40%). Subjects were shown two screens with "back" and "next" navigation buttons at either the top or bottom of the screen. 24% thought it was equally easy to find the buttons; of those with a preference, 74% preferred them at the bottom. <b>Conclusions:</b> Trial sponsors should consider incorporating these patient preference results into the design of ePRO instruments, potentially reducing subject burden and increasing patient engagement in COPD clinical trials.

Objectives: The patient-physician axis of communication is critical for effective monitoring and treatment of COPD. Our objective was to characterize the current role of technology in patient/physician communication and identify patient preferences for this interaction. Methods: We surveyed 100 subjects in the U.S. with COPD; questions focused on patients9 technology use and preferences for communicating with their physician. Results: Subjects ranged in age from 34 to 86 years and were 55% female. 39% owned a smartphone and 41% reported using the internet daily or weekly. Most subjects (65%) reported that when they track or monitor their disease, they share their results with their physician. Subjects reported that doing online research about their disease might lead them to ask more questions about medication (46%), treatment options (45%), and new technologies to help manage their disease (34%). Over half of subjects (52%) reported that they always understand information their physicians share with them, but of those who require clarification, 54% call their physician, while others ask family and friends (35%), use internet research (28%), or wait until their next clinical visit (24%). Most subjects preferred a phone call from their physician (91%) if they needed to be contacted between visits, rather than a text message (19%) or email (17%). Conclusions: Most subjects with COPD are already sharing their results from tracking and monitoring their disease with their physician, and prefer the telephone for between-visit communication. Programs seeking to improve patient-physician communication with technology can draw from this baseline knowledge to identify potential areas for intervention.

PurposeThe use of serotonin type 3 (5-HT3) receptor antagonists (RAs) in the prevention of nausea and vomiting caused by emetogenic chemotherapy is part of a comprehensive management strategy for patients undergoing chemotherapy. Electrocardiographic effects have been reported in patients after intravenous administration of 5-HT3 RAs. The present study investigated the electrocardiogram (ECG) profile of the 5-HT3 RA palonosetron following International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E14 Guidelines.MethodsA total of 221 healthy subjects (101 females, 120 males) were randomized in this phase I, double-blind, double-dummy, parallel group study and assigned to one of five treatments: placebo, palonosetron (0.25, 0.75, or 2.25 mg), or moxifloxacin (400 mg). ECGs were recorded for 24 h pre-dosing until 48 h post-dose. The primary endpoint was the placebo time-matched and baseline-subtracted individual QTc interval prolongation (ΔΔQTcI).ResultsThe QTc interval was not prolonged after administration of palonosetron (ΔΔQTcI upper confidence interval was <10 ms for all time points in all palonosetron treatment groups). Assay sensitivity was confirmed with the expected change in the QTc interval after administration of the positive control moxifloxacin.ConclusionsPalonosetron, even at supratherapeutic doses, has no effect on cardiac repolarization as measured by the QTc interval in a validated controlled clinical trial.

Background: Eleutherococcus senticosus radix (also known as “Siberian ginseng” or “eleuthero”) is used as a medicinal plant in cases of asthenia with fatigue and weakness, a condition especially common in elderly patients. Most reviews and monographs state the contraindication “arterial hypertension”. This excludes many elderly patients from therapy with eleuthero, as the prevalence of arterial hypertension in this age group is high. The origin and substantiation of this contraindication appears, however, unclear. Methods: Available data on eleuthero in the context of hypertension was searched and evaluated systematically for an increase in blood pressure after application of corresponding preparations. Results: Numerous clinical and preclinical studies with eleuthero, as well as reviews and monographs were identified. All sources directly or indirectly refer to only two Russian publications from 1966, presented to the Western world in a review in 1985. Later citations of these two Russian sources tended to mix up the results described therein, frequently indicating the observation of secured adverse effects in hypertensive patients. Such warnings are neither in accordance with the original data, nor are they supported by other published data, which rather point to potential antihypertensive effects. Conclusion: The contraindication “arterial hypertension” is not evidence-based and should be carefully re-evaluated for not unnecessarily excluding a large patient group from the benefits of eleuthero. Keywords: Eleutherococcus senticosus , Siberian ginseng, eleuthero, arterial hypertension, contraindication

To assess the joint relationships among body mass index, menopausal status, and breast cancer according to breast cancer subtype and estrogen-progestin medication use, we conducted a meta-analysis of 89 epidemiologic reports published in English during 1980-2012 identified through a systematic search of bibliographic databases. Pooled analysis yielded a summary risk ratio of 0.78 (95% confidence interval (CI): 0.67, 0.92) for hormone receptor-positive premenopausal breast cancer associated with obesity (body mass index (weight (kg)/height (m)(2)) ≥30 compared with <25). Obesity was associated with a summary risk ratio of 1.39 (95% CI: 1.14, 1.70) for receptor-positive postmenopausal breast cancer. For receptor-negative breast cancer, the summary risk ratios of 1.06 (95% CI: 0.70, 1.60) and 0.98 (95% CI: 0.78, 1.22) associated with obesity were null for both premenopausal and postmenopausal women, respectively. Elevated postmenopausal breast cancer risk ratios associated with obesity were limited to women who never took estrogen-progestin therapy, with risk ratios of 1.42 (95% CI: 1.30, 1.55) among never users and 1.18 (95% CI: 0.98, 1.42) among users; too few studies were available to examine this relationship according to receptor subtype. Future research is needed to confirm whether obesity is unrelated to receptor-negative breast cancer in populations of postmenopausal women with low prevalence of hormone medication use.