Objectives: Intrathecal drug delivery (ITDD) devices have been shown to be a clinically effective and cost-effective option for the management of cancer pain and recommended for use in England. The aim of this study is to assess the impact of the 2015 NHS England Clinical Commissioning Policy on the uptake of ITDD pumps for the management of cancer pain or if there is an ongoing unmet need for this intervention in England. Materials and Methods: Hospital Episode Statistics (HES) were obtained for all patients undergoing ITDD for the management of cancer pain between 2014 and January 2020. In addition, HES were utilized to estimate the number of patients with cancer potentially eligible for ITDD pump during the same period. Results: The number of patients with cancer and those potentially suitable to receive an ITDD for the management of cancer pain have increased year on year since 2014. This increase has not been matched by an uptake in the provision of ITDD. Conservative estimates suggest that at least 8000 people with cancer pain would be eligible for ITDD; 458 patients received an intervention for pain management between April 2018 and March 2019 and only 30 ITDD pumps were implanted in that same period. Conclusions: We observed a substantial gap between the need and provision of ITDD for patients with refractory cancer pain in England despite the recommendation for the use of ITDD for this patient population. In addition, we present suggestions for improvement of access to and provision of ITDD in England.

Objectives To identify the most frequently used atrial fibrillation-specific quality of life (QoL) instruments across atrial fibrillation (AF) ablation studies and to perform a systematic review of the most frequently used instrument’s measurement properties. This study uses quality of life instruments as an overarching term for any patient reported outcome measure that assesses a person’s health related well-being, functional status, and disease related symptoms. Methods A literature mapping exercise was undergone to identify the most frequently used AF-specific QoL instruments across AF ablation studies published from 2016 to 2021. A systematic review of the most frequently used AF QoL instruments identified from the mapping exercise was performed using the COSMIN guidelines for systematic reviews of patient-reported outcome measurements. A systematic search was conducted in Ovid MEDLINE, Ovid Embase, Ovid PsycINFO, EBSCO CINAHL, and Cochrane CENTRAL. The search used variations of the keywords “atrial fibrillation”, “quality of life”, and “catheter ablation”. Results Forty-five instruments were identified via the literature mapping exercise. After excluding non-patient reported outcome instruments, non-AF specific instruments, and instruments appearing only once, six instruments were identified: AF Effect on QualiTy-of-Life (AFEQT), AF Severity Scale, Minnesota Living with Heart Failure Instrument, AF Quality of Life Instrument, Arrhythmia Specific instrument in Tachycardia and Arrhythmia (ASTA), and SCL (Arrhythmia Symptom Checklist, Frequency and Severity). A systematic review of these six AF-specific health related QoL instruments was performed. We screened 3221 articles and 17 studies were eligible for inclusion. Using the COSMIN guidelines, ASTA and AFEQT had the best ratings across measurement properties with both instruments having good ratings for instrument development and internal consistency. However, none of the 17 included articles assessed measurement error and cross-cultural validity. Conclusions AFEQT and ASTA had the strongest measurement properties but not all measurement properties were assessed. Considering the large number of indeterminate and insufficient ratings, future research should focus on cross-cultural validation, measurement error, responsiveness, and interpretability. This review summarizes the current evidence for AF QoL instruments across AF ablation studies and outlines areas for future research.

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Funding Acknowledgements Type of funding sources: Other. Main funding source(s): This cost-effectiveness study was funded by Medtronic Background The UK National Institute of Care Excellence (NICE) recommend the use of pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) in those who have not responded to drug treatment. Recently, three randomized controlled trials have demonstrated that as an initial rhythm control strategy, PVI with cryoballoon ablation, reduces atrial arrhythmia recurrence compared to antiarrhythmic drug (AAD) therapy in patients with symptomatic PAF. Purpose To evaluate the cost-effectiveness of first-line cryoablation versus first-line optimized AADs in an English National Health Service (NHS) setting. Methods Individual patient-level data from 703 participants with untreated PAF recruited into Cryo-FIRST, STOP AF First and EARLY-AF were used to derive equations to predict the following outcomes: rates of ablation, AF recurrence and resolution, AF-related hospital attendance, and health-related quality of life (HRQoL) utilities. Where parameters could not be sourced from the trial data, inputs were taken from the published literature or derived using clinical expert opinion. The cost-effectiveness model (CEM) was a hybrid of a decision tree with a one-year time horizon and a Markov model (three-month cycle length) with a lifetime time horizon and was developed from the perspective of the English NHS. Health benefits were expressed in quality-adjusted life years (QALYs), and all benefits and costs were discounted at 3.5% per year in line with NICE requirements. Uncertainty in the CEM inputs was explored using probabilistic sensitivity analysis. The results include an initial 12-week blanking period for all studies. Results The three-monthly rate of AF recurrence was reduced on average by 46.7% (p<0.001) in those treated with cryoablation. Similarly, the monthly rate of receiving an ablation following initial treatment was reduced by 72.8% (p<0.001) in the cryoablation arm. Furthermore, the average cryoablation patient was associated with a 4.3% (p=0.025) increase in their HRQoL. While the likelihood of failure was greater in the AAD group, in those who failed initial treatment, there was no difference in the rate of AF symptom resolution. The CEM indicates that cryoablation is more effective (+0.17 QALYs) and more costly (+£1,414) over a lifetime compared to optimized AADs. Cryoablation resulted in an Incremental Cost-Effectiveness Ratio of £8,435 with a 78.5% probability of being cost-effective at a willingness-to-pay threshold of £20,000 per QALY gained. Individuals in both treatment arms were predicted to receive ~1.2 ablations over a lifetime regardless of initial treatment. However, there was a 45% relative reduction in the amount of time spent in symptomatic AF states for those initially treated with cryoablation. Conclusions AF rhythm control in drug naïve patients with cryoballoon ablation is cost-effective compared to optimized AADs in an English NHS setting.

Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic Background Atrial fibrillation (AF) is the most common arrhythmia worldwide. A key objective of AF management is symptom reduction, as quality of life (QoL) is lower for patients with AF. QoL outcomes are important for evaluating AF therapies primarily indicated for symptom control, including catheter ablation. The aim of this systematic review is to identify the most frequently used QoL instruments across AF ablation studies and to critically appraise their measurement properties. Methods and results A literature mapping exercise was completed to identify the most frequently used QoL instruments in AF ablation studies published in the past five years. A systematic review was then undertaken to critically appraise the measurement properties of the identified QoL instruments: EQ-5D, SF-36, AFEQT (AF Effect on QualiTy-of-Life), AFSS (AF Severity Scale), MLHF-Q (Minnesota Living with Heart Failure Questionnaire), AFQLQ (AF Quality of Life Questionnaire), ASTA (Arrhythmia Specific questionnaire in Tachycardia and Arrhythmia), and SCL (Arrhythmia Symptom Checklist, Frequency and Severity). The systematic review was designed using the COSMIN guidelines for systematic reviews of patient-reported outcome measurements, and was focused on the measurement properties of validity, reliability, and responsiveness. A systematic search of the literature was conducted in Ovid MEDLINE, Ovid Embase, Ovid PsycINFO, EBSCO CINAHL, and Cochrane CENTRAL. A meta-analysis was not feasible due to significant heterogeneity between studies and measurement properties, therefore results were synthesized qualitatively. 17 studies and 8 instruments were identified that met the eligibility criteria. ASTA and AFEQT had the best ratings across measurement properties with both instruments having good ratings for prom development and internal consistency. However, none of the studies assessed measurement error and cross-cultural validity. Measurement properties were inconsistent across different studies appraising the same instrument. Conclusions AFEQT and ASTA had the strongest measurement properties but not all measurement properties have been assessed. Considering the large number of indeterminate and insufficient ratings, future research should focus on cross-cultural validation, measurement error, responsiveness, and interpretability.