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Background: Although surgical resection has been considered the only curative option for colorectal liver metastases, thermal ablation has recently been suggested as an alternative curative treatment. There have been no adequately powered trials comparing surgery with thermal ablation., Objectives: Main objective - to compare the clinical effectiveness and cost-effectiveness of thermal ablation versus liver resection surgery in high surgical risk patients who would be eligible for liver resection. Pilot study objectives - to assess the feasibility of recruitment (through qualitative study), to assess the quality of ablations and liver resection surgery to determine acceptable standards for the main trial and to centrally review the reporting of computed tomography scan findings relating to ablation and outcomes and recurrence rate in both arms., Design: A prospective, international (UK and the Netherlands), multicentre, open, pragmatic, parallel-group, randomised controlled non-inferiority trial with a 1-year internal pilot study., Setting: Tertiary liver, pancreatic and gallbladder (hepatopancreatobiliary) centres in the UK and the Netherlands., Participants: Adults with a specialist multidisciplinary team diagnosis of colorectal liver metastases who are at high surgical risk because of their age, comorbidities or tumour burden and who would be suitable for liver resection or thermal ablation., Interventions: Thermal ablation conducted as per local policy (but centres were encouraged to recruit within Cardiovascular and Interventional Radiological Society of Europe guidelines) versus surgical liver resection performed as per centre protocol., Main Outcome Measures: Pilot study - patients' and clinicians' acceptability of the trial to assist in optimisation of recruitment. Primary outcome - disease-free survival at 2 years post randomisation. Secondary outcomes - overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, and disease-free survival measured from end of intervention. It was planned that 5-year survival data would be documented through record linkage. Randomisation was performed by minimisation incorporating a random element, and this was a non-blinded study., Results: In the pilot study over 1 year, a total of 366 patients with colorectal liver metastases were screened and 59 were considered eligible. Only nine participants were randomised. The trial was stopped early and none of the planned statistical analyses was performed. The key issues inhibiting recruitment included fewer than anticipated patients eligible for both treatments, misconceptions about the eligibility criteria for the trial, surgeons' preference for one of the treatments ('lack of clinical equipoise' among some of the surgeons in the centre) with unconscious bias towards surgery, patients' preference for one of the treatments, and lack of dedicated research nurses for the trial., Conclusions: Recruitment feasibility was not demonstrated during the pilot stage of the trial; therefore, the trial closed early. In future, comparisons involving two very different treatments may benefit from an initial feasibility study or a longer period of internal pilot study to resolve these difficulties. Sufficient time should be allowed to set up arrangements through National Institute for Health Research (NIHR) Research Networks., Trial Registration: Current Controlled Trials ISRCTN52040363., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 21. See the NIHR Journals Library website for further project information., Competing Interests: Julia Brown is a member of Health Technology Assessment (HTA) Mental, Psychological and Occupational Health Methods Group, HTA Clinical Trials Committee, HTA Prioritisation Committee Methods Group and HTA Funding Committee Policy Group. Stephen Morris was formerly a member of the National Institute for Health Research (NIHR) Health Services and Delivery Research (HSDR) Research Funding Board, the NIHR HSDR Commissioned Board, the NIHR HSDR Evidence Synthesis Sub Board, the NIHR Unmet Need Sub Board, the NIHR HTA Clinical Evaluation and Trials Board, the NIHR HTA Commissioning Board, the NIHR Public Health Research (PHR) Research Funding Board and the NIHR Programme Grants for Applied Research (PGfAR) expert subpanel. Maureen Twiddy is a member of the Research for Patient Benefit North East and Yorkshire Advisory Panel. Brian Davidson is chairperson of the London NIHR Research for Patient Benefit panel. Daniel Hochhauser reports Medical Research Council CASE studentship with Merck Serono (Darmstadt, Germany). Kurinchi Gurusamy reports grants from NIHR, Cancer Research UK Multidisciplinary Award, UK Oncology Nursing Society, University College London and Wellcome Trust/Department of Health and Social Care – Health Innovation Challenge Fund 4 – Smart Surgery, during the conduct of the study.

Objective: To validate the NHSLA maternity claims taxonomy at the level of a single maternity service and assess its ability to direct quality improvement., Design: Qualitative descriptive study., Setting: Medico-legal claims between 1 January 2000 and 31 December 2016 from a maternity service in metropolitan Melbourne, Australia., Population: All obstetric claims and incident notifications occurring within the date range were included for analysis., Methods: De-identified claims and notifications data were derived from the files of the insurer of Victorian public health services. Data included claim date, incident date and summary, and claim cost. All reported issues were coded using the NHSLA taxonomy and the lead issue identified., Main Outcome Measures: Rate of claims and notifications, relative frequency of issues, a revised taxonomy., Results: A combined total of 265 claims and incidents were reported during the 6 years. Of these 59 were excluded, leaving 198 medico-legal events for analysis (1.66 events/1000 births). The costs for all claims was $46.7 million. The most common claim issues were related to management of labour (n = 63, $17.7 million), cardiotocographic interpretation (n = 43, $24.4 million), and stillbirth (n = 35, $656,750). The original NHSLA classification was not sufficiently detailed to inform care improvement programmes. A revised taxonomy and coding flowchart is presented., Conclusions: Systematic analysis of obstetric medico-legal claims data can potentially be used to inform quality and safety improvement., Tweetable Abstract: New taxonomy to target health improvement from maternity claims based on NHSLA Ten Years of Maternity Claims., (© 2019 Royal College of Obstetricians and Gynaecologists.)