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Aim: To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS)., Methods: Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources., Results: In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses., Conclusions: This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.

Aims: To scope the key performance indicators (KPIs) used in nursing and midwifery across the United Kingdom and Republic of Ireland and explore how they influence practice in healthcare organizations., Design: The study adopted a sequential, exploratory mixed-methods design., Methods: Phase 1 incorporated a multiple-choice questionnaire completed by 77 Directors of Nursing recruited using voluntary response sampling. In phase 2, 35 nurses and midwives who were working at executive, senior manager and clinical levels, participated in semi-structured interviews. Data collection of both phases was conducted from January 2016 to October 2016., Findings: Quantitative data revealed over 100 nursing and midwifery-specific KPIs. National requirements were a deciding factor in KPI selection, while clinical involvement was mainly through data collection. Respondents stated that they used patient experience KPIs, but only one was assessed as valid. Thematic analysis identified two themes: The leadership challenge (including 'voiceless in the national conversation', 'aligning KPIs in the practice context' and 'listening to those who matter'); and taking action (including 'establishing ownership and engaging staff', 'checks and balances' and 'closing the loop')., Conclusion: The large volume of KPI measurement taking place makes meaningful evaluation of performance and quality of care difficult, both in and across organizations. Nurses and midwives require enhanced knowledge of the nature and purpose of KPIs, as evidence gained from KPI data collection is insufficient to lead to improvements in practice. A practice context that encourages collective leadership, where multiple sources of evidence are gathered and everyone is included in KPI evaluation and subsequent decision-making, is key., Impact: This study adds to the body of evidence on KPI understanding. It informs the future effective management of indicators that will facilitate the delivery of meaningful care and reduce the cost, time and effort invested in the implementation of KPIs and data management., (© 2021 John Wiley & Sons Ltd.)