Use of telephone and web interfaces of interactive response technology at clinical investigator sites in clinical trials.

BACKGROUND: Interactive response technologies are used in clinical trials to provide services such as automated randomization and medication logistics management. The objective of this article is to investigate the usage of telephone (Interactive Voice Response) and web (Interactive Web Response) interfaces of interactive response technologies at clinical investigator sites in clinical trials, to obtain information about the preferences of interactive response technology end users between the telephone and web interfaces, and to explore the relevance of the telephone interface in this setting. METHODS: The data consist of an online survey conducted in spring 2016 with clinical investigators, study nurses, and pharmacists in 13 countries. RESULTS: Ninety-eight percent of survey respondents preferred the web interface over the telephone interface, the most important reason being superior usability. However, the respondents indicated the usability of interactive response technology interfaces is not optimal, and lack of integration and consistency across systems is common. A vast majority of interactive response technology end users at clinical sites prefer to use the web interface over the telephone interface, but most also feel there would need to be a back-up system. CONCLUSIONS: Based on the results, it would be beneficial to improve the usability of the interactive response technology interfaces, and to increase consistency across systems from the current level. Support to and training of the users, as well as clarifying the responsibilities between sites and the sponsor should also be a focal point. Study sponsors should explore with interactive response technology service providers how removing the telephone interface would impact future studies, and whether there could be a more efficient means to achieve a reliable back-up to the web interface instead of a dedicated telephone interface.

Efficacy, safety and tolerability of the CCR1 antagonist BAY 86-5047 for the treatment of endometriosis-associated pelvic pain: a randomized controlled trial.

INTRODUCTION: Antagonism of CC chemokine receptor type 1 (CCR1) may provide a novel treatment approach for women with symptomatic endometriosis. Studies of CCR1 antagonists in these patients have not been reported. MATERIAL AND METHODS: Women (n = 110; 18-45 years) with symptomatic endometriosis were randomized to BAY 86-5047 or placebo for 12 weeks. Pelvic pain was assessed using the visual analogue scale (VAS) and women recorded the intake of pain medication in a diary. The primary efficacy outcome was a composite of the absolute change in VAS score and the cumulative change in consumption of analgesics between baseline and the end of treatment. Safety assessments included adverse events, blood and urine evaluation and electrocardiography. RESULTS: Mean VAS scores decreased from 64.8 mm at baseline to 49.2 mm at week 12 in the BAY 86-5047 group and from 67.2 mm to 47.8 mm in the placebo group. The proportion of women using analgesics decreased from 33.9% to 11.5% or from 44.4% to 15.4% for patients who received BAY 86-5047 or placebo, respectively. There was no significant difference between the two treatment groups in terms of change in VAS scores (p = 0.45) or intake of analgesics (p = 0.82). A three-step sensitivity analysis failed to show superiority of BAY 86-5047 over placebo (p = 0.67). BAY 86-5047 was well tolerated and no significant safety concerns arose during the study. CONCLUSIONS: Based on these results, BAY 86-5047 is unlikely to be useful in the treatment of women with endometriosis-associated pelvic pain.

Adherence with ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen supported by the use of a digital tablet dispenser with or without acoustic alarm: an open-label, randomized, multicenter study.

OBJECTIVE: To evaluate the effect of a digital dispenser's acoustic alarm function on adherence to ethinylestradiol (EE) 20 µg/drospirenone 3 mg in a flexible extended regimen (EE/drospirenoneFlex) among women in five European countries (France, Germany, Italy, Spain, UK) seeking oral contraception. STUDY DESIGN: Randomized, parallel-group open-label study. METHODS: Women aged 18-35 years received EE/drospirenoneFlex administered in a regimen with cycle lengths of their choice with the aid of a digital pill dispenser over 1 year. In group A (N=250), the dispenser's acoustic alarm was activated (ie, acoustic alarm + visual reminder). In group B (N=249), the acoustic alarm was deactivated (ie, visual reminder only). In addition, the women recorded pill intake daily in diary cards. The primary efficacy variable was the mean delay of daily pill release after the dispenser reminded the woman to take a pill (reference time). Secondary efficacy variables included number of missed pills, contraceptive efficacy, bleeding pattern, tolerability, and user satisfaction. RESULTS: Dispenser data showed a mean (standard deviation [SD]) daily delay in pill release of 88 (126) minutes in group A vs 178 (140) minutes in group B (P<0.0001). Median (lower quartile, Q1; upper quartile, Q3) number of missed pills was 0 (0; 1) in group A vs 4 (1; 9) in group B (P<0.0001). Diary card results revealed similar trends; however, underreporting of missed pills was evident in both groups. No pregnancies were reported during 424 women-years of exposure. Across the two groups, the mean (SD) EE/drospirenoneFlex cycle length was 51.0 (31.8) days with strong regional differences, and the mean (SD) number of bleeding/spotting days was 50.4 (33.0) days. EE/drospirenoneFlex was well tolerated, and 80% of women were satisfied with treatment. CONCLUSION: The dispenser's activated acoustic alarm improved adherence with daily tablet intake of EE/drospirenoneFlex, reducing missed pills. EE/drospirenoneFlex provided effective contraception and a good tolerability profile.

Rapid diagnostic method for quantitative testing of <100 microbes in water.

A robust, real-time polymerase chain reaction (RT-PCR) system to universally detect microbes at a limit of 10 to 50 colony-forming units within 5-6 h was developed. Pre-treatment of RT-PCR master mixes with ethidiumbromide monoacide (EMA) facilitates the development of an RT-PCR assay with appropriate sensitivity, reproducibility, and recovery.The system is useful to replace conventional microbial plating techniques for the analysis of microbial contamination in liquids like water. This was statistically confirmed for eight different bacteria and two different fungi species. Finally a complete procedure including microbial lysis, DNA extraction, EMA treatment, and RT-PCR was developed and evaluated for three different bacteria and two fungi species.