Vaidya, Jayant S; Williams, Norman R; Bulsara, Max; Brew-Graves, Chris; Potyka, Ingrid; Roberts, Nicolas J; LIndsay, Julia; ... Jeffrey, Tobias S; + view all Vaidya, Jayant S; Williams, Norman R; Bulsara, Max; Brew-Graves, Chris; Potyka, Ingrid; Roberts, Nicolas J; LIndsay, Julia; Laws, Siobhan; Raj, Sanjay; Douek, Michael; Falzon, Mary; Petralia, Gloria; Needleman, Sarah; Malhotra, Anu; Benstein, Marcelle; Jeffrey, Tobias S; - view fewer (2025) A novel methodology using direct patient contact and UK national registries to collect long-term data from randomised trials: Extended follow up of the TARGIT-A trial of intraoperative radiotherapy for breast cancer (TARGIT-X). Presented at: British Association of Surgical Oncology ~ Association for Cancer Surgery Annual confierence 2025, London, UK.

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Abstract

Background: Many diseases such as breast cancer have a long natural history requiring follow-up longer than traditionally funded in clinical trials. / Method: The randomised TARGIT-A trial compared targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) vs whole breast radiotherapy. We assessed the feasibility of recording health status of patients by annual patient contact directly from the trials unit, and NHS Digital data (hospital episodes, new diagnoses and death). Funding: NIHR-HTA:14/49/13 / Results: 607 of 714 UK patients originally recruited from March-2000 to June-2012 in the TARGIT-A trial were initially eligible. From 2018 to 2024, we ascertained the health status (n=502) or reason for non-participation (n=72), total n=574/607(94.5%). 107 were too unwell or had died. Less than 5% (25/502) patients were unwilling to participate: 23 declined and 2 withdrew. The quality of data returned by patients was very good (e.g., mismatch rate for recording date <0.1%(1/1470 forms). We recorded an additional 103 deaths, more than doubling the initial number to 203. Patients who participated increased their follow up by a median 6 years (to 14 years (IQR 13 to 16)). The cost, including research funds, was < £60/patient/year of follow up, in spite of the considerable increase in cost for NHS Digital data over the study period. / Conclusion: In the UK, 95% patients are willing to be followed-up long-term. It is feasible to collect data for long-term health conditions by direct patient contact plus NHS Digital, at a low cost, even during the COVID-19 pandemic: an approach adoptable for other randomised clinical trials.

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