The aim is to develop a Core Outcome Set (COS) to be measured and reported in all trials of therapeutic mammaplasty, for clinical use and in audit. The COS will reflect the views of patients and the multidisciplinary team (oncoplastic breast surgeons, plastic surgeons and breast care nurses). The project will also aim to identify the most appropriate way to measure these outcomes.
ContributorsPrincipal Investigator: Mr Daniel Leff
Lead Investigator: Dr Alice Lee
Collaborator: Mr Richard Kwasnicki
Disease Category: Cancer
Disease Name: Breast cancer
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Surgery
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Systematic review of outcome measures/measurement instruments
- Systematic review of outcomes measured in trials
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Survey
- Systematic review
Protocol: a protocol will be written with input from patient representatives and multidisciplinary professionals. The protocol will cover the use of systematic reviews and qualitative interviews with patients for long listing and the use of Delphi surveys and consensus meetings to create the final COS.
Study oversight: A steering group consisting of researchers, multidisciplinary professionals and ideally a patient representative will be formed.
Outcome long listing:
- Systematic review of electronic databases (EMBASE, Medline, Web of science, CINAHL, Cochrane) to identify clinical studies of therapeutic mammaplasty. Data extracted will include: outcomes (short and long term, clinical and patient reported), when these outcomes are measured and the tools used to measure the outcome. Outcomes will be grouped into domains using the most appropriate ontological system described in the COMET handbook.
- Qualitative interviews: patients and their carers will be invited to one-to-one interviews and focus groups. Demographic details and details of their surgical procedure will be collected. Patients will be asked about their experience of therapeutic mammaplasty and which outcomes matter to them. The outcomes derived from the systematic review will be presented for discussion and critique. The sessions will be audio recorded with consent. Additional outcomes will be identified through a process of inductive thematic or framework analysis (dependent on data generated) and added to the long list generated from the systematic review.
Determining core outcomes:
A Delphi survey with multiple stakeholders (patients, healthcare professionals) will be conducted. The healthcare professional group will include surgeons and breast care nurses. There will be a joint consensus meeting with healthcare professionals and patients to finalise the COS.
COSMIN methodology will be used to assess the quality of measurement tools identified in the systematic review and to determine how core outcomes should be measured.