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Background & Aims: Thermal ablation of the defect margin after endoscopic mucosal resection (EMR-T) for treating large (≥20 mm) nonpedunculated colorectal polyps (LNPCPs) has shown efficacy in a randomized trial, with a 4-fold reduction, in residual or recurrent adenoma (RRA) at first surveillance colonoscopy (SC1). The clinical effectiveness of this treatment, in the real world, remains unknown., Methods: We sought to evaluate the effectiveness of EMR-T in an international multicenter prospective trial (NCT02957058). The primary endpoint was the frequency of RRA at SC1. Detailed demographic, procedural, and outcome data were recorded. Exclusion criteria were LNPCPs involving the ileo-caecal valve, the appendiceal orifice, and circumferential LNPCPs., Results: During 51 months (May 2016-August 2020) 1049 LNPCPs in 1049 patients (median size, 35 mm; interquartile range, 25-45 mm; right colon location, 53.5%) were enrolled. Uniform completeness of EMR-T was achieved in 989 LNPCPs (95.4%). In this study, 755/803 (94.0%) eligible LNPCPs underwent SC1 (median time to SC1, 6 months; interquartile range, 5-7 months). For LNPCPs that underwent complete EMR-T, the frequency of RRA at SC1 was 1.4% (10/707)., Conclusions: In clinical practice, EMR-T is a simple, inexpensive, and highly effective auxiliary technique that is likely to significantly reduce RRA at first surveillance. It should be universally used for the management of LNPCPs after EMR. https://clinicaltrials.gov; Clinical Trial Number, NCT02957058., (Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.)

Objective The South Australian Medicines Evaluation Panel (SAMEP) was established in 2011 to make evidence-based recommendations on the funding of high-cost medicines in South Australian public hospitals via a high-cost medicines formulary. SAMEP represents one component of South Australia's process for state-based health technology assessment (HTA). The aim of this study was to describe the experience of SAMEP in the context of Australia's complex governance model for hospital-based care. Methods A retrospective review was conducted of the SAMEP process and outcomes of medicine evaluations. Decision summaries and meeting minutes were reviewed and reflected upon by the authors to explore the views of the SAMEP membership regarding the function of the committee and state-based HTA more broadly. Results SAMEP has reviewed 29 applications, with 14 (48%) listed on the high-cost medicines formulary. Three applications have been the subject of outcome review and confirm expectations of patient benefit. Conclusion Retrospective review of the committee experience suggests that state-based HTA as operationalised by SAMEP is feasible, provides greater equity of access to high-cost medicines in the South Australian public hospital system and allows for access with evidence development. What is known about the topic? State-based hospital funders often need to make decisions on the provision of high-cost medicines for which there is no national guidance or subsidy. Little published information exists about state-based approaches to medicines evaluation and reimbursement within public hospitals in Australia. What does this paper add? The South Australian experience demonstrates a method for states and territories to tackle the challenges of providing evidence-based access to high-cost medicines in Australian public hospitals. What are the implications for practitioners? This paper provides information for other jurisdictions considering state-based approaches to medicines evaluation and contributes to the broader literature about state-based HTA in Australia.

Background & Aims: Colorectal cancer (CRC) can be prevented by colonoscopy and polypectomy. Endoscopic mucosal resection (EMR) is performed to remove large laterally spreading colonic lesions that have a high risk of progression to CRC. Endoscopically invisible micro-adenomas at the margins of the EMR site might contribute to adenoma recurrence, which occurs in 15% to 30% of patients who undergo surveillance. We aimed to determine the efficacy of adjuvant thermal ablation of the EMR mucosal defect margin in reducing polyp recurrence., Methods: We performed a prospective study of 390 patients with large laterally spreading colonic lesions (≥ 20 mm, n = 416) referred for EMR at 4 tertiary centers in Australia. After complete lesion excision by EMR, lesions were randomly assigned to thermal ablation of the post-EMR mucosal defect margin (n = 210) or no additional treatment (controls, n = 206). We performed surveillance colonoscopies with standardized photo documentation and biopsies of the scar after 5 to 6 months. Patient, procedure, and lesion characteristics were similar between the groups. The primary endpoint was detection of lesion recurrence at first surveillance colonoscopy., Results: A significantly lower proportion of patients who received thermal ablation of the post-EMR mucosal defect margin had evidence of recurrence at first surveillance colonoscopy (10/192, 5.2%) than controls (37/176, 21.0%) (P < .001). The relative risk of recurrence in the thermal ablation group was 0.25 compared with the control group (95% confidence interval 0.13-0.48). Rates of adverse events were similar between the groups., Conclusions: In a multicenter randomized trial, thermal ablation of the post-EMR mucosal defect margin significantly reduced polyp recurrence at first surveillance colonoscopy, compared with no additional treatment. Routine implementation of this simple and safe technique could increase the utility of EMR, decrease surveillance burdens, and reduce morbidity and mortality from CRC. ClinicalTrials.gov no: NCT01789749., (Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.)

We investigated recruitment into a randomised controlled trial (RCT) following contact with a generalist telephone counselling service. Telephone counsellors were required to ask callers if they would be willing to receive a telephone call to discuss their possible involvement in a trial designed to evaluate the use of a web-based mental health intervention. The five centres involved answered a total of 34,722 counselling calls during the recruitment period. Only 9% of callers were invited by the telephone counsellor to receive the recruitment call and of all callers, only 2.6% agreed. Common reasons reported by the telephone counsellors for not referring eligible applicants to the trial included their view that it was inappropriate to ask the caller, feeling uncomfortable about asking the question, being concerned that the invitation might affect the counselling relationship and forgetting to ask. The presence of an on-site trial manager, regular encouragement and feedback, and tailored and specific recruiter training may improve rates of recruitment in future trials.

The increasing need to consider rationing strategies within the healthcare environment is being driven by pressures such as the development of new medical technologies, the aging population, patient awareness and expectations, healthcare professionals' appetite for new treatments, and government restrictions on healthcare costs. Solutions to these pressures will need to be sought urgently to avoid a situation in which quality of healthcare is affordable only for the wealthy. The fundamental principles of equity and fairness will need to be applied universally if the solutions are to be accepted by the community, patients and practitioners. There are several measures that a hospital must have in place before the concept of drug rationing can be contemplated. The approach essentially involves ensuring rational drug approval processes based on critical review of the available data, coupled with ongoing education and audit. Thus, accurate information and clinical budgeting systems, processes which encourage and ensure structural and technical efficiencies within the drug use sequence and an effective Drug and Therapeutics committee are required to facilitate this approach. To assist with its overriding goals of the quality use of medicines and optimal patient care, the Drug and Therapeutics committee needs to implement an effective formulary system, obtain detailed guidelines governing drug use within the institution, conduct an ongoing drug utilisation review programme, and provide education and training. The move to consider allocative decision making (rationing) will become increasingly necessary as limits on structural and technical efficiency measures are reached. An institution will then need to decide whether to treat a particular group of patients, or provide a certain form of treatment. Improved methods for community consultation need to be explored and there must be a partnership between the health provider and the consumer in enunciating the existence of scarcity, determining priorities and ensuring that ethics and equity are not abandoned through this process.