Quantifying the relationship between disability progression and quality of life in patients treated for NMOSD: Insights from the SAkura studies.

BACKGROUND: To date, no specific scales have been developed to explore the impact of neuromyelitis optica spectrum disorder (NMOSD)-related disability on quality of life (QoL). The Expanded Disability Status Scale (EDSS) and the EuroQol 5-dimensions (EQ-5D) have been used to assess disability and QoL, respectively, in patients with NMOSD. However, there is limited evidence surrounding their use in this condition. We compared EDSS and EQ-5D data across two clinical trials to quantify the relationship between disability and QoL in patients with NMOSD. METHODS: SAkuraSky (NCT02028884) and SAkuraStar (NCT02073279) were Phase 3, multicenter, randomized, international, double-blind, placebo-controlled, parallel-assignment studies of satralizumab, administered in combination with baseline immunosuppressants (SAkuraSky) or as monotherapy (SAkuraStar). EDSS and EQ-5D were assessed at baseline and at 24-week intervals thereafter. The relationship between disability and QoL was assessed by estimating EQ-5D utilities (UK tariff) for each incremental EDSS category. A repeated-measures linear model was used to regress health utilities on EDSS score-derived health states. RESULTS: Overall, 176 patients underwent at least one EDSS assessment and completed an EQ-5D survey and were included in this analysis. There was a clear association between mean EQ-5D score and EDSS score, with decreases in QoL being observed at each incremental increase in disability. The relationship between EDSS and EQ-5D score remained consistent across the different treatment groups. CONCLUSIONS: These results, generated from high-quality clinical trial data, demonstrated a strong and consistent relationship between disability and QoL in patients with NMOSD.

Real-world costs of transvenous lead extraction: the challenge for reimbursement.

AIMS: Transvenous lead extraction is challenging, often requiring specialist equipment and prolonged hospital admission. A single tariff or itemized costs may be available for reimbursement. Due to limited data relating to the costs of transvenous extraction, it is unclear whether either form of reimbursement is adequate. We aim to describe accurately the total real-world costs of managing patients undergoing transvenous extraction at a single, large centre. We further aim to consider the additional costs of device reimplantation. METHODS AND RESULTS: At a single UK extraction centre, a retrospective, patient level service line analysis was undertaken, during a complete financial year. Seventy-four patients required transvenous extraction (47 infected and 27 non-infected; 156 leads). Sixty-nine procedures (93%) were performed under general anaesthesia, with a median time in theatre of 95 min [interquartile range (IQR) 71-120]. Specialist extraction tools were required for 130 leads (83%). The median hospitalization duration was 3 days (IQR 1-8). The mean cost of extraction was £9228 (±4099); infected £10 727 (±4178) and non-infected £6619 (±2269). With the additional costs of device reimplantation, the overall mean cost rose to £17 574 (±12 882); infected £22 615 (±13 343) and non-infected £8801 (±5007). At the time of this study, the UK NHS tariff was £2530 for elective and £4764 for non-elective extraction, covering barely half of the real costs. CONCLUSION: We demonstrated a substantial difference between the real-world cost of extraction and the UK NHS tariff. Extracting centres should scrutinize their practice, including the timing of reimplantation.

Treatment for newly diagnosed hypertension: patterns of prescribing and antihypertensive effectiveness in the UK.

Improved practice in the management of hypertension depends on an understanding of existing patterns of treatment. To describe the management of newly diagnosed hypertension in British general practice and the effectiveness of current prescribing patterns we conducted a retrospective observational study using data from a computerized general practitioner record database (DIN-LINK). 21 024 patients were first treated for newly diagnosed hypertension between January 1993 and December 1997, and were followed for 4 years. Diuretics or beta-blockers were the most widely prescribed first-line treatments, used in 54% of patients. The mean continuation rate for first-line therapy was 69% at 12 months: the continuation rate was highest for angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists. After 12 months of treatment the mean blood pressure reduction was 19/10 mmHg. Blood pressure targets were met in only 14% of patients. After 48 months of treatment 34% of patients had not improved in band of blood pressure severity. Many patients with severe hypertension at 12 months were still being prescribed only one drug. The lack of aggression in antihypertensive treatment, indicated by the low number of agents prescribed and the failure to achieve targets, is disappointing. Prescribing patterns for first-line therapy corresponded to guidelines. Continuation rates on first-line therapy were higher than often reported. The choice of drug for additions to or switches from first-line therapy had no clear pattern. Routinely collected computerized data could be used to support clinical governance activities in primary care.