BackgroundEarly detection of oesophageal cancer improves outcomes; however, the optimal strategy for identifying patients at increased risk from the pre-cancerous lesion Barrett’s oesophagus (BE) is not clear. The Cytosponge, a novel non-endoscopic sponge device, combined with the biomarker Trefoil Factor 3 (TFF3) has been tested in four clinical studies. It was found to be safe, accurate and acceptable to patients.The aim of the BEST3 trial is to evaluate if the offer of a Cytosponge-TFF3 test in primary care for patients on long term acid suppressants leads to an increase in the number of patients diagnosed with BE.MethodsThe BEST3 trial is a pragmatic multi-site cluster-randomised controlled trial set in primary care in England. Approximately 120 practices will be randomised 1:1 to either the intervention arm, invitation to a Cytosponge-TFF3 test, or the control arm usual care. Inclusion criteria are men and women aged 50 or over with records of at least 6 months of prescriptions for acid-suppressants in the last year. Patients in the intervention arm will receive an invitation to have a Cytosponge-TFF3 test in their general practice. Patients with a positive TFF3 test will receive an invitation for an upper gastro-intestinal endoscopy at their local hospital-based endoscopy clinic to test for BE.The primary objective is to compare histologically confirmed BE diagnosis between the intervention and control arms to determine whether the offer of the Cytosponge-TFF3 test in primary care results in an increase in BE diagnosis within 12 months of study entry.DiscussionThe BEST3 trial is a well-powered pragmatic trial testing the use of the Cytosponge-TFF3 test in the same population that we envisage it being used in clinical practice. The data generated from this trial will enable NICE and other clinical bodies to decide whether this test is suitable for routine clinical use.Trial registrationThis trial was prospectively registered with the ISRCTN Registry on 19/01/2017, trial number ISRCTN68382401.Electronic supplementary materialThe online version of this article (10.1186/s12885-018-4664-3) contains supplementary material, which is available to authorized users.
Social media provides a useful platform for informal discussions about healthcare. Acceptability is key to the uptake of diagnostic devices and this can be difficult to gauge from questionnaires and qualitative studies. The aim of this study is to investigate whether Facebook could be used to gauge public perception toward uptake of a new diagnostic test for Barrett's esophagus called the Cytosponge. We retrospectively reviewed Facebook comments relating to a video on the Cytosponge. We categorized comments into: (1) Positive, (2) Negative, (3) Unknown and (4) Questions. Recurring themes that arose were compared to a qualitative study on the Cytosponge. The video received 22.5 million views and 2837 comments within four months. Of these, 525 comments were positive, 215 were unknown, 179 were negative, 71 were questions, and 1847 were 'Tagged' comments. Among positive comments, recurrent themes were that it was innovative, could lead to early cancer-detection, and more favorable than endoscopy. Among negative comments, a recurring theme was concern about the risk of gagging and vomiting. Among 'questions', a recurring theme was related to the risk of Cytosponge detachment. We compared our analysis to a published qualitative study and found similar themes arose across both studies. Facebook provides a rich source of qualitative data, which could be used to augment studies to gauge public perception toward a new diagnostic test.
ObjectivesPatient and public involvement (PPI) in health research is required by some funders and publications but we know little about how common it is. In this study we estimated the frequency of PPI inclusion in health research papers and analysed how it varied in relation to research topics, methods, funding sources and geographical regions.DesignCross-sectional.MethodsOur sample consisted of 3000 research papers published in 2020 in a general health-research journal (BMJ Open) that requires a statement on whether studies included PPI. We classified each paper as ‘included PPI’ or ‘did not include PPI’ and analysed the association of this classification with location (country or region of the world), methods used, research topic (journal section) and funding source. We used adjusted regression models to estimate incident rate ratios of PPI inclusion in relation to these differences.Results618 (20.6%) of the papers in our sample included PPI. The proportion of papers including PPI varied in relation to location (from 44.5% (95% CI 40.8% to 48.5%) in papers from the UK to 3.4% (95% CI 1.5% to 5.3%) in papers from China), method (from 38.6% (95% CI 27.1% to 50.1%) of mixed-methods papers to 5.3% (95% CI –1.9% to 12.5%) of simulation papers), topic (from 36.9% (95% CI 29.1% to 44.7%) of papers on mental health to 3.4% (95% CI –1.3% to 8.2%) of papers on medical education and training, and funding source (from 57.2% (95% CI 51.8% to 62.6%) in papers that received funding from the UK’s National Institute for Health Research to 3.4% (95% CI 0.7% to 6.0%) in papers that received funding from a Chinese state funder).ConclusionsMost research papers in our sample did not include PPI and PPI inclusion varied widely in relation to location, methods, topic and funding source.
OBJECTIVES: Many key pharmaceutical markets (including England, Scotland, Canada and Australia) have Health Technology Assessment (HTA) bodies for which cost-utility analyses are key criteria. For such bodies, acceptable cost per Quality-Added Life Year (QALY) based on the manufacturer's submitted price must be demonstrated. By contrast, in other major markets (such as France and Germany), a level of added benefit is ascribed to a drug and based upon this a price is negotiated. However, the expansion of international reference pricing means that prices in major ex-US markets are increasing converging. Thus the major difference between such agencies becomes the coverage, which this research compares, using the example of 2 recent high cost breast cancer therapies. METHODS: Publically available HTA reports for Kadcyla and Perjeta from the pan-Canadian Oncology Review (pCODR),
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