A comparison of the cost-effectiveness of intramedullary nail fixation and locking plate fixation in the treatment of adult patients with an extra-articular fracture of the distal tibia: economic evaluation based on the FixDT trial.

Aims: The aim of this study was to compare the cost-effectiveness of intramedullary nail fixation and 'locking' plate fixation in the treatment of extra-articular fractures of the distal tibia. Patients and Methods: An economic evaluation was conducted from the perspective of the United Kingdom National Health Service (NHS) and personal social services (PSS), based on evidence from the Fixation of Distal Tibia Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients were available for analysis. Costs were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality adjusted life year (QALY) gained, and net monetary benefit. Sensitivity analyses were conducted to test the robustness of cost-effectiveness estimates. Results: Mean NHS and PSS costs were significantly lower for patients treated with an intramedullary nail than for those treated with a locking plate (-£970, 95% confidence interval (CI) -1685 to -256; p = 0.05). There was a small increase in QALYs gained in the nail fixation group (0.01, 95% CI -0.03 to 0.06; p = 0.52). The probability of cost-effectiveness for nail fixation exceeded 90% at cost-effectiveness thresholds as low as £15 000 per additional QALY. The cost-effectiveness results remained robust to several sensitivity analyses. Conclusion: This trial-based economic evaluation suggests that nail fixation is a cost-effective alternative to locking plate fixation. Cite this article: Bone Joint J 2018;100-B:624-33.

Labour induction near term for women aged 35 or over: an economic evaluation.

OBJECTIVE: Induction of labour at 39 weeks for nulliparous women aged 35 years and over may prevent stillbirths and does not increase caesarean births, so it may be popular. But the overall costs and benefits of such a policy have not been compared. DESIGN: A cost-utility analysis alongside a randomised controlled trial (the 35/39 trial). SETTING: Obstetric departments of 38 UK National Health Service hospitals and one UK primary-care trust. POPULATION: Nulliparous women aged 35 years or over on their expected due date, with a singleton live fetus in a cephalic presentation. METHODS: Costs were estimated from the National Health Service and Personal Social Services perspective and quality-adjusted life-years (QALYs) were calculated based on patient responses to the EQ-5D at baseline and 4 weeks. MAIN OUTCOME MEASURES: Data on antenatal care, mode of delivery, analgesia in labour, method of induction, EQ-5D (baseline and 4 weeks postnatal) and participant-administered postnatal health resource use data were collected. RESULTS: The intervention was associated with a mean cost saving of £263 and a small additional gain in QALYs (though this was not statistically significant), even without considering any possible QALY gains from stillbirth prevention. CONCLUSION: A policy of induction of labour at 39 weeks for women of advanced maternal age would save money. TWEETABLE ABSTRACT: A policy of induction of labour at 39 weeks of gestation for women of advanced maternal age would save money.

Development of a repository of individual participant data from randomized controlled trials of therapists delivered interventions for low back pain.

BACKGROUND: Individual patient data (IPD) meta-analysis of existing randomized controlled trials (RCTs) is a promising approach to achieving sufficient statistical power to identify sub-groups. We created a repository of IPD from multiple low back pain (LBP) RCTs to facilitate a study of treatment moderators. Due to sparse heterogeneous data, the repository needed to be robust and flexible to accommodate millions of data points prior to any subsequent analysis. METHODS: We systematically identified RCTs of therapist delivered intervention for inclusion to the repository. Some were obtained through project publicity. We requested both individual items and aggregate scores of all baseline characteristics and outcomes for all available time points. The repository is made up of a hybrid database: entity-attribute-value and relational database which is capable of storing sparse heterogeneous datasets. We developed a bespoke software program to extract, transform and upload the shared data. RESULTS: There were 20 datasets with more than 3 million data points from 9328 participants. All trials collected covariates and outcomes data at baseline and follow-ups. The bespoke standardized repository is flexible to accommodate millions of data points without compromising data integrity. Data are easily retrieved for analysis using standard statistical programs. CONCLUSIONS: The bespoke hybrid repository is complex to implement and to query but its flexibility in supporting datasets with varying sets of responses and outcomes with different data types is a worthy trade off. The large standardized LBP dataset is also an important resource useable by other LBP researchers. SIGNIFICANCE: A flexible adaptive database for pain studies that can easily be expanded for future researchers to map, transform and upload their data in a safe and secure environment. The data are standardized and harmonized which will facilitate future requests from other researchers for secondary analyses.

Economic costs associated with moderate and late preterm birth: a prospective population-based study.

OBJECTIVE: We sought to determine the economic costs associated with moderate and late preterm birth. DESIGN: An economic study was nested within a prospective cohort study. SAMPLE: Infants born between 32(+0) and 36(+6)  weeks of gestation in the East Midlands of England. A sample of infants born at ≥37 weeks of gestation acted as controls. METHODS: Data on resource use, estimated from a National Health Service (NHS) and personal social services perspective, and separately from a societal perspective, were collected between birth and 24 months corrected age (or death), and valued in pounds sterling, at 2010-11 prices. Descriptive statistics and multivariable analyses were used to estimate the relationship between gestational age at birth and economic costs. MAIN OUTCOME MEASURES: Cumulative resource use and economic costs over the first two years of life. RESULTS: Of all eligible births, 1146 (83%) preterm and 1258 (79%) term infants were recruited. Mean (standard error) total societal costs from birth to 24 months were £12 037 (£1114) and £5823 (£1232) for children born moderately preterm (32(+0) -33(+6)  weeks of gestation) and late preterm (34(+0) -36(+6)  weeks of gestation), respectively, compared with £2056 (£132) for children born at term. The mean societal cost difference between moderate and late preterm and term infants was £4657 (bootstrap 95% confidence interval, 95% CI £2513-6803; P < 0.001). Multivariable regressions revealed that, after controlling for clinical and sociodemographic characteristics, moderate and late preterm birth increased societal costs by £7583 (£874) and £1963 (£337), respectively, compared with birth at full term. CONCLUSIONS: Moderate and late preterm birth is associated with significantly increased economic costs over the first 2 years of life. Our economic estimates can be used to inform budgetary and service planning by clinical decision-makers, and economic evaluations of interventions aimed at preventing moderate and late preterm birth or alleviating its adverse consequences. TWEETABLE ABSTRACT: Moderate and late preterm birth is associated with increased economic costs over the first 2 years of life.