ArticlePilot and feasibility studies2022
The challenge of equipoise: qualitative interviews exploring the views of health professionals and women with multiple ipsilateral breast cancer on recruitment to a surgical randomised controlled feasibility trial.
Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03514654 (Can Patients With Multiple Breast Cancers in the Same Breast Avoid Mastectomy by Having Multiple Lumpectomies to Achieve Equivalent Rates of Local Breast Cancer Recurrence? A Randomised Controlled Feasibility Study.), which is not on this map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Can Patients With Multiple Breast Cancers in the Same Breast Avoid Mastectomy by Having Multiple Lumpectomies to Achieve Equivalent Rates of Local Breast Cancer Recurrence? A Randomised Controlled Feasibility Study.
Who cites it
8 citing papers in PubMed, 11 citations in OpenAlex.
- Aesthetic Outcomes and Patient-Reported Outcomes of Volume Replacement (Chest Wall Perforator Flaps) versus Volume Displacement: An Observational Study.Aesthetic plastic surgery · 2026Observational
- Clinical Trials and Their Implementation: Lessons Learned.Annals of surgical oncology · 2025Article
- Trends in Facial Reanimation Surgery: A Bibliometric Analysis.Plastic and reconstructive surgery. Global open · 2025Article
- Mapping the current landscape of locoregional therapy de-escalation trials in early breast cancer: a systematic review.NPJ breast cancer · 2025Article
- Clinical and patient-reported outcomes in women offered oncoplastic breast-conserving surgery as an alternative to mastectomy: ANTHEM multicentre prospective cohort study.The British journal of surgery · 2024Article
- Local Recurrence After Breast-Conserving Therapy in Patients With Multiple Ipsilateral Breast Cancer: Results From ACOSOG Z11102 (Alliance).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Article
- The unifying concepts of the sick lobe hypothesis, field cancerisation and breast conservation treatment for multiple ipsilateral breast cancers: a narrative review.Gland surgery · 2023Review
- Oncoplastic and reconstructive breast surgery.Frontiers in oncology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundA multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020. The MIAMI surgical trial aimed to investigate recruitment of sufficient numbers of women. Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.
methodsInterviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.
resultsOverarching themes of (1) influences on equipoise and recruitment and (2) effects of a lack of equipoise were generated. Within these themes, health professional themes described the barriers to recruitment as 'the treatment landscape has changed', 'staff preferences and beliefs' which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of 'altruism and timing of trial approach', 'influences from consultants and others' and 'diagnostic journey doubts' all played a part in whether patients agreed to take part in the trial.
conclusionsBarriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.
trial registrationISRCTN ( ISRCTN17987569 ) registered on April 20, 2018, and ClinicalTrials.gov ( NCT03514654 ).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.