Home Invasive Mechanical Ventilation Users Quality of Life: Is Response Shift Supported?

The use of home invasive mechanical ventilation (HIMV) has risen over the past ten years due to improved health outcomes, transitioning more complex care to the home, and evidence supports the benefits of this therapy. In order to plan care for this population, it is important to understand issues that affect an individual’s quality of life (QoL). Previous research provided mixed results, limited guidance of factors that affect QoL, and lacked a theoretical framework that lends questions to validity. The first manuscript, Home Invasive Mechanical Ventilation Users’ Quality of Life: A Review of Literature, provides a literature review of available research focused on HIMV and QoL. The second manuscript, Response Shift Theory: A Deep Dive, reviews available research on Response Shift Theory (RST) in order to provide in-depth understanding of concepts presented within the theory. The third manuscript, Home Invasive Mechanical Ventilator User Quality of Life: Is Response Shift Theory Supported?, reports a single critical case study design to understand if RST was supported by qualitative data obtained from an HIMV user. The purposes of this study were to determine the extent that RST explains QoL in a user of HIMV, how RST concepts explain QoL and why RST concepts do not explain QoL. This dissertation portfolio opens the door to creating interventions and assessment techniques that affect QoL for HIMV users

Using an Escape Room toolbox approach to enhance pharmacology education

Background: Faculty are encouraged to use a variety of teaching/learning strategies to engage nursing students. While simulation and games are now common, there were no reports in the nursing literature using an “escape room” concept. Escape rooms use an entertainment approach as teams engage in critical thinking to solve puzzles and find clues to escape a room. In the classroom setting, this concept is modified to solve a mystery by finding various objects through a series of puzzles to locate clues. Some of these games involve finding numerical clues to open locks on a box, such as a toolbox. The purpose of this study was to describe the use of a toolbox gaming strategy based on an escape room concept to help students learn about cardiovascular medications in a pharmacology course. Methods: This pilot study employed a descriptive qualitative method to investigate an approach to pharmacology education. The sample consisted of first semester nursing students. Results: Student responses to criteria-based questions resulted in three themes: engaging, teamwork, and frustration, related to using a toolbox scenario strategy as a pathway to learning. Conclusions: This descriptive study yielded mixed results from the students who were frustrated by time constraints but engaged in the learning experience. Lessons are offered for future improvements

Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study

Background Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial. Methods We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76 hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II\ue2\u80\u93IV disease, vaccination against Neisseria meningitides, and previous treatment with at least two immunosuppressive therapies or one immunosuppressive therapy and chronic intravenous immunoglobulin or plasma exchange for 12 months without symptom control. Patients with a history of thymoma or thymic neoplasms, thymectomy within 12 months before screening, or use of intravenous immunoglobulin or plasma exchange within 4 weeks before randomisation, or rituximab within 6 months before screening, were excluded. We randomly assigned participants (1:1) to either intravenous eculizumab or intravenous matched placebo for 26 weeks. Dosing for eculizumab was 900 mg on day 1 and at weeks 1, 2, and 3; 1200 mg at week 4; and 1200 mg given every second week thereafter as maintenance dosing. Randomisation was done centrally with an interactive voice or web-response system with patients stratified to one of four groups based on MGFA disease classification. Where possible, patients were maintained on existing myasthenia gravis therapies and rescue medication was allowed at the study physician's discretion. Patients, investigators, staff, and outcome assessors were masked to treatment assignment. The primary efficacy endpoint was the change from baseline to week 26 in MG-ADL total score measured by worst-rank ANCOVA. The efficacy population set was defined as all patients randomly assigned to treatment groups who received at least one dose of study drug, had a valid baseline MG-ADL assessment, and at least one post-baseline MG-ADL assessment. The safety analyses included all randomly assigned patients who received eculizumab or placebo. This trial is registered with ClinicalTrials.gov, number NCT01997229. Findings Between April 30, 2014, and Feb 19, 2016, we randomly assigned and treated 125 patients, 62 with eculizumab and 63 with placebo. The primary analysis showed no significant difference between eculizumab and placebo (least-squares mean rank 56\uc2\ub76 [SEM 4\uc2\ub75] vs 68\uc2\ub73 [4\uc2\ub75]; rank-based treatment difference \ue2\u88\u9211\uc2\ub77, 95% CI \ue2\u88\u9224\uc2\ub73 to 0\uc2\ub796; p=0\uc2\ub70698). No deaths or cases of meningococcal infection occurred during the study. The most common adverse events in both groups were headache and upper respiratory tract infection (ten [16%] for both events in the eculizumab group and 12 [19%] for both in the placebo group). Myasthenia gravis exacerbations were reported by six (10%) patients in the eculizumab group and 15 (24%) in the placebo group. Six (10%) patients in the eculizumab group and 12 (19%) in the placebo group required rescue therapy. Interpretation The change in the MG-ADL score was not statistically significant between eculizumab and placebo, as measured by the worst-rank analysis. Eculizumab was well tolerated. The use of a worst-rank analytical approach proved to be an important limitation of this study since the secondary and sensitivity analyses results were inconsistent with the primary endpoint result; further research into the role of complement is needed. Funding Alexion Pharmaceuticals