Patients' and surgeons' experiences after failed breast reconstruction: A qualitative study.

BACKGROUND: The goal of postmastectomy breast reconstruction (BR) is to improve the quality of life of patients. However, complications following autologous BR (A-BR) and implant-based BR (I-BR) occur frequently and may even lead to BR-failure, which can be a distressing event for both patients and surgeons. The current study, therefore, examines the experiences of both patients and surgeons after a BR-failure. METHODS: Patients with a failed BR from a large multicenter cohort study and participating plastic surgeons were invited to participate in semi-structured interviews focusing on their experiences. The interviews were analyzed according to the principles of grounded theory. RESULTS: Fourteen patients with a failed I-BR, four patients with a failed A-BR, and four plastic surgeons were participated. Three main categories emerged from the data: personal experiences with BR-failure, the motives for a redo of a failed BR, and patient-surgeon communication. Patients would like to be treated with more attention to their personal feelings and lives, instead of being approached from a purely medical-technical perspective. Surgeons may experience feelings of guilt leading to the strong urge to fix the failed BR, whereas patients may be less inclined to undergo additional operations. Patients want to know what the choice for a particular type of BR would mean to their personal lives. The impact of I-BR-failure may be underestimated and requires the same degree of intensive aftercare and attention. CONCLUSIONS: Implementing the recommendations of this study in clinical practice may facilitate improvements in how both patients and surgeons cope with a BR-failure.

Patients' decision-making, experiences and preferences regarding pixantrone treatment in relapsed or refractory diffuse large B-cell lymphoma: study protocol for a longitudinal mixed methods study.

INTRODUCTION: There is a lot of speculation about why and how patients decide to use invasive treatment in an advanced stage of cancer, but the body of research is limited. The present longitudinal qualitative and quantitative study reflects real-life practice of pixantrone use and aims to collect data on patients' considerations for, expectations of and experiences with pixantrone and trajectories in their quality-of-life (QoL) values in a Dutch clinical setting. Hence, two questions emerge. Why do patients choose for this treatment, while the treatment success rate is limited and curation cannot be achieved? And second, once chosen, what conditions would patients like to satisfy and how do they experience the treatment? METHODS AND ANALYSIS: This is a non-interventional longitudinal and multicentre study. Patients are eligible if they are >18 years, have never been treated with pixantrone before, have an Eastern Cooperative Oncology Group performance score ≤2, have a relapsed or refractory diffuse large B-cell lymphoma and have been treated with at least two prior regimens. The decision to treat patients with pixantrone has been taken by the treating physician before patients are asked to participate in the study. If patients refuse study participation after being informed by the investigator, reasons for refusal (if given) will be recorded. Participants will receive at least three interviews accompanied by three QOL questionnaires. Based on the required sample size, we aim to include 20 patients over a period of 2 years. ETHICS AND DISSEMINATION: The Medical Ethical Committee of Erasmus MC, Rotterdam, The Netherlands, has approved this study. The results will be disseminated in peer-reviewed journals and major international conferences. The study is non-interventional and falls therefore not under Medical Research Involving Human Subjects Act (In Dutch: Wet medisch-wetenschappelijk onderzoek met mensen; WMO). Hence, this study is approved to be carried out in the Erasmus MC. Each other participating centre will receive this approval and will separately undergo the ethical approval to be able to participate. In addition to the ethical approval, the participating centres need to obtain written informed consent of their patients. Given the non-interventional nature of this study, a study registration was considered but deemed unnecessary. The study will be conducted in accordance with the Declaration of Helsinki (Tokyo, Venice, Hong Kong and Somerset West amendments). A sequential identification number will be automatically attributed to each patient that has given consent to participate in the study. This number will identify the patient and must be included on all documents. Only the main researcher can link the code to the patient's identity.