Clinical management of breast cancer in NHS Tayside: risk assessment of the Healthcare Improvement Scotland report

Annex A: Clinical Management of Breast Cancer in NHS Tayside – Immediate Review Group (IRG)

Terms of Reference (ToR)

1. Background

An oncology lead pharmacist in NHS Tayside contacted the CMO, CPO and the previous Cabinet Secretary for Health & Sport to raise concerns relating to the breast cancer clinical management guidelines and alleged ‘under-dosing’ of oncology medicines, lack of informed consent and a separate, but related, bullying and harassment complaint. The latter will be considered separately from this work being the responsibility of NHS Tayside.

The CMO and CPO commissioned Healthcare Improvement Scotland (HIS) to undertake an investigation into the clinical management of breast cancer in NHS Tayside. This investigation has now concluded and a draft final report has been produced. This report highlights some key areas for concern;

A. Patients in NHS Tayside were being treated differently from the patients in the rest of NHS Scotland with chemotherapy in the adjuvant and neo-adjuvant setting. The decision to treat differently lacked evidence or multidisciplinary consultation. 

B. Breast Cancer patients in NHS Tayside were not informed during the consent process of that difference and the potential consequences.

C. Patients in NHS Tayside were not offered Oncotype DX Testing in the planning of therapy. 

2. Purpose

This group will advise the CMO and CPO on the content and implications for patients of the HIS report. It will assess the potential risk of the variation in practice. Thereafter, will work with NHS Tayside on the practical response to allay concerns and/or recall patients.

Specifically the group will advise the CMO and CPO on the following main questions:

• Is the variation in practice seen elsewhere in NHS Scotland (the HIS report says not) or in NHS England? Is this variation considered to be within acceptable clinical practice?
• The IRG will specifically assess the risk of a reduction in dose across the duration of adjuvant/neo-adjuvant treatment. Can an estimate of harm/increased risk of recurrence be made? Can this be mitigated in any way?
• Is the practice of using NHS Predict rather than offering Oncotype DX testing seen elsewhere? Is any harm caused mitigated by the NHS Predict tool use?
• Would established best practice mandate that such a variation against universally adopted practice be communicated to patients during the consent process?

3. Governance

The group will report to the CMO and CPO who will then report to the Cabinet Secretary for Health & Sport.

4. Membership

The membership will consist of:

Members will be expected to attend each meeting of the group.

5. Meetings

Due to the time pressure on this process meetings will be virtual.