Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: study protocol of a randomized multi-center phase III trial-AkniPro 2.

BACKGROUND: A previously performed phase III trial on 112 subjects investigating prophylactic nimodipine treatment in vestibular schwannoma (VS) surgery showed no clear beneficial effects on preservation of facial and cochlear nerve functions, though it should be considered that protection of facial nerve function was the primary outcome. However, the risk for postoperative hearing loss was halved in the nimodipine group compared to the control group (OR 0.49; 95% CI 0.18-1.30; p = 0.15). Accordingly, this phase III extension trial investigates the efficacy and safety of prophylactic nimodipine for hearing preservation in VS surgery. METHODS: This is a randomized, multi-center, two-armed, open-label phase III trial with blinded expert review and two-stage with interim analysis. Three hundred thirty-six adults with the indication for microsurgical removal of VS (Koos I-IV) and serviceable preoperative hearing (Gardner-Robertson scale (GR) 1-3) are assigned to either the therapy (intravenous nimodipine 1-2 mg/h from the day before surgery until the fifth postoperative day and standard of care) or the control group (surgery only and standard of care). The primary endpoint of the trial is postoperative cochlear nerve function measured before discharge according to GR 1-3 versus GR 4-5 (binary). Hearing function will be determined by pre- and postoperative audiometry with speech discrimination, which will be evaluated by a blinded expert reviewer. Furthermore, patient-reported outcomes using standardized questionnaires will be analyzed. DISCUSSION: Prophylactic parenteral nimodipine treatment may have a positive effect on hearing preservation in VS surgery and would improve patient's quality of life. Further secondary analyses are planned. Except for dose-depending hypotension, nimodipine is known as a safe drug. In the future, prophylactic nimodipine treatment may be recommended as a routine medication in VS surgery. VS can be considered as an ideal model for clinical evaluation of neuroprotection, since hearing outcome can be classified by well-recognized criteria. The beneficial effect of nimodipine may be transferable to other surgical procedures with nerves at risk and may have impact on basic research. TRIAL REGISTRATION: EudraCT 2019-002317-19, DRKS00019107 . 8th May 2020.

Interactive patient education via an audience response system in cardiac rehabilitation.

OBJECTIVES: Patient education and compliance play an important role in the success of rehabilitation in cardiovascular diseases. The aim of this study is to analyze whether interactive learning methods, in this study, the audience response system with a "clicker," can improve the learning success of patients during and after their rehabilitation process. METHODS: In a randomized, prospective cohort study, a total of 260 patients were randomized to either an interactive training group using Athens audience response system or to a control group without the use of audience response system during the educational sessions. Patients were taught and tested on four different topics concerning their primary disease: heart failure, arterial hypertension, prevention of cardiovascular diseases, and coronary heart disease. After each session, the patients had to answer questions on the previously taught topics via questionnaires. These questions were asked again at the day of discharge, as well as 3 and 12 months after discharge. Additional information on the patients' health, plus their mental status, was gathered with the help of further questionnaires (HADS and SF-12). RESULTS: A total of 260 patients (201 men and 59 women) were recruited. The patients were on average 61.1 ± 11 years old. A significant short-term effect on the patients' knowledge about their disease was found immediately after the educational sessions in the intervention group. However, there was no long-term effect in either the intervention or control group. Although there was no statistical significance found in any of the observations, a positive short-term effect on learning capacity as well as positive trends in mental and physical health after discharge could be found in patients after the use of audience response system during their rehabilitation. CONCLUSION: This study provides interesting and new data on the use of an interactive learning method for patients to gain knowledge about their primary disease and eventually improve their physical and mental health status in a long-term perspective. By implementing different and new ways of teaching and interaction during the hospitalization, not only patients, but also medical staff and caregivers could benefit.