The iBRA (implant breast reconstruction evaluation) study

Conditions

Implant-based breast reconstruction following mastectomy for breast cancer or risk reduction Cancer

Emma Sewart, Nicholas Turner, Elizabeth J. Conroy, Ramsey Cutress, Joanna Skillman et al. (10 authors)

Annals of Surgery2020-07-0915 citations

Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study

Gareth T. Davies, Nicola Mills, Chris Holcombe, Shelley Potter, Shelley Potter

Trials2020-04-0618 citations

10.1186/s13063-020-4227-1

Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study.

Potter S, Conroy EJ, Cutress RI, Williamson PR, Whisker L, Thrush S, Skillman J, Barnes NLP, Mylvaganam S, Teasdale E, Jain A, Gardiner MD, Blazeby JM, Holcombe C, iBRA Steering Group, Breast Reconstruction Research Collaborative.

2019-01-09126 citations

10.1016/s1470-2045(18)30781-2

The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction.

Potter S, Conroy EJ, Williamson PR, Thrush S, Whisker LJ, Skillman JM, Barnes NL, Cutress RI, Teasdale EM, Mills N, Mylvaganam S, Branford OA, McEvoy K, Jain A, Gardiner MD, Blazeby JM, Holcombe C, Breast Reconstruction Research Collaborative.

2016-08-0420 citations

10.1186/s40814-016-0085-8

Interventions

Phase 1 – A national practice questionnaire (NPQ) The aim of phase 1 is to understand the current practice of implant-based breast reconstruction in the UK to inform the design of a d

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patients 2. Undergoing immediate IBBR for malignancy or risk-reduction under the care of the breast or plastic surgeons

Exclusion criteria

Exclusion criteria: 1. Women undergoing delayed breast reconstruction 2. Revisional surgery 3. Patients not willing or able to provide informed consent for the patient reported outcomes part of the study

Design outcomes

Primary

Measure	Time frame
The feasibility study will determine the most appropriate study design. The primary outcome will be identified and outcome data used to inform a sample size calculation. Information from rates of surgery and patient selection criteria will be combined with estimates of surgeon and centre willingness to participate in a trial to assess the feasibility of undertaking a definitive trial that would achieve target recruitment within 3 years. The following specific progression criteria will be reviewed at 30 months: 1. At least 40% of surgeons and patients responding to the RCT-Acceptability Survey can agree to participate in an RCT in implant-based breast reconstruction surgery 2. The cohort study data and findings of the RCT-Acceptability Surveys (for patients and surgeons) and qualitative work provide sufficient information to inform the selection of an acceptable and appropriate primary outcome measure to inform the sample size required for main study. 3. Based on the sample size calculation for the chosen primary outcome, the number of centres willing to participate, the anticipated patient consent rate, and data from the incident numbers of patients that are likely to be eligible to participate in a RCT, including information about reconstructive techniques used and to be compared in the trial, the study will be practical and achievable with three years of recruitment. Data from an analysis of NIHR portfolio data (Kaur, MRC North West Hub for Trials Methodology Research, personal communication) shows that the trials recruiting to time and target did so with a median recruitment period of 13 months, interquartile range 8 to 24. 42/45 (93%) recruited successfully within three years. Although these data are for paediatric trials, there is no obvious reason why the results would not be generalisable to recruitment in adult studies. 4. Data from the surveys show that a sufficient number of	—

Measure

Time frame

The feasibility study will determine the most appropriate study design. The primary outcome will be identified and outcome data used to inform a sample size calculation. Information from rates of surgery and patient selection criteria will be combined with estimates of surgeon and centre willingness to participate in a trial to assess the feasibility of undertaking a definitive trial that would achieve target recruitment within 3 years. The following specific progression criteria will be reviewed at 30 months: 1. At least 40% of surgeons and patients responding to the RCT-Acceptability Survey can agree to participate in an RCT in implant-based breast reconstruction surgery 2. The cohort study data and findings of the RCT-Acceptability Surveys (for patients and surgeons) and qualitative work provide sufficient information to inform the selection of an acceptable and appropriate primary outcome measure to inform the sample size required for main study. 3. Based on the sample size calculation for the chosen primary outcome, the number of centres willing to participate, the anticipated patient consent rate, and data from the incident numbers of patients that are likely to be eligible to participate in a RCT, including information about reconstructive techniques used and to be compared in the trial, the study will be practical and achievable with three years of recruitment. Data from an analysis of NIHR portfolio data (Kaur, MRC North West Hub for Trials Methodology Research, personal communication) shows that the trials recruiting to time and target did so with a median recruitment period of 13 months, interquartile range 8 to 24. 42/45 (93%) recruited successfully within three years. Although these data are for paediatric trials, there is no obvious reason why the results would not be generalisable to recruitment in adult studies. 4. Data from the surveys show that a sufficient number of

—

Secondary

Measure	Time frame
Optimal design and conduct of the RCT	—

Countries

England, Northern Ireland, United Kingdom, Wales

Outcome results

None listed