Background and guidelines
According to Cancer Research UK, a GP with 2,000 patients is likely to see only one woman each year who has breast cancer. However, they will see many patients with non-malignant breast conditions, such as cysts, breast pain and diffuse nodularity.
To help GPs minimise the risk of a delayed or missed diagnosis, we have reviewed advisory complaints relating to breast cancer received by members to see if there were any recurring themes.
An analysis of complaints received by MDU members following a breast cancer diagnosis between 2012 and 2016 found that 84 related to a missed or delayed diagnosis. Fifty-two of these related to a missed diagnosis and 32 related to a delayed diagnosis, where the alleged delay ranged between 26 days and 43 months.
Seventy-seven complaints related to GP members, with six being consultants and one being a trainee. This is not surprising given that most patients will present to see their GP in the first instance if they are concerned about a breast lump or other associated symptoms.
Eighty-one patients were in the 30 and over age group and of those 36 were aged 50 and over.
Signs and symptoms
The most common presenting symptom was a lump (68%) and/or pain (42%), and therefore according to the NICE guidance (see below) these patients could appropriately have been referred urgently under the two week wait. Other symptoms included nipple changes and weight loss.
While the presence or absence of a breast lump was always noted in the records, this was not the case for some other signs and symptoms including pain, any changes to the nipple or the presence of lymph nodes.
Other features of the patient's history, such as whether or not there was a past or family history of breast disease, and the presence of other risks factors like smoking or the use of hormone replacement therapy or the oral contraceptive pill, were present in a quarter of the patient's notes that were reviewed. Past history included previous breast malignancy, benign lumps, and mastitis and breast cysts. There was no record of a past history of breast disease in eight of the case notes and no reference to a family history in 39 or other risk factors in 16 of the notes.
Of those who were 30 years and over, 62 patients with signs or symptoms fulfilling the criteria for urgent referral under the two week wait were not referred in accordance with NICE guidance. All of these patients complained of a lump with or without pain. Three patients had changes to the nipple as well as a lump and six were recorded as having had lymph nodes palpable. A number of diagnoses were given to the patients to explain their symptoms, including fibroadenoma, benign cyst or lump, generalised nodularity, blocked milk duct or cyclical/hormonal changes.
Where a patient presented with a lump, the presence of other signs and symptoms was not always noted.
All of the patients aged 50 years or over had signs or symptoms that should have led to an urgent referral. The majority of these had a lump, but some had other symptoms such as breast pain or changes to the nipple. Differential diagnosis for these patients included fibroadenoma, hormonal changes or musculoskeletal pain.
Most patients who were ultimately diagnosed with breast cancer were in their 30s, 40s and 50s, so urgent referral guidelines would have applied. It is particularly important, therefore, that any patient seen with symptoms in these age groups is taken seriously and a diagnosis of breast cancer is carefully considered. Good justification would be needed for not referring a patient where they fulfil the relevant criteria.
History and findings
A quarter of patients were recorded to have either a relevant past history of breast disease, a family history or risk factors for developing breast cancer. However this information was often not mentioned in the clinical notes and therefore there was no evidence as to whether these factors had been considered by the doctor, or whether the doctor had asked about them but a negative response led them not to record it in the records.
This highlights the importance of doctors also recording relevant negative findings when assessing patients. Information about a patient's family history of breast disease or other risk factors may influence whether or not a referral is felt to be appropriate and is also important information to include in the referral letter.
Noting a family history may indicate that other family members may be at risk, and so a referral to a clinical genetics department may also be warranted. It is more difficult to defend allegations made by a patient that certain questions were not asked, if there is no mention of the response to the question in the records.
Complaints and investigations
Where a doctor has not followed the relevant guidelines without good justification, they could be vulnerable to criticism by the GMC. Fourteen of the files analysed also involved a GMC investigation.
Five complaints were also referred to the Health Services Ombudsman, where presumably the complainant had not been satisfied with the response they received during the local resolution stage. As well as making recommendations about clinical care, including record keeping, the Ombudsman can also recommend redress payments. Patients may also seek compensation by pursuing a clinical negligence claim and this was found to be the case in 21 of the files analysed. Some patients may decide not to make a complaint at all and pursue a claim from the outset.
The National Institute for Health and Care Excellence (NICE) and Healthcare Improvement Scotland (HIS) produce guidelines for GPs to help them decide when specialist referral is appropriate.
According to the NICE 'suspected cancer pathway referral' breast cancer patients should be referred for an appointment within two weeks if they are aged 30 and over and have an unexplained breast lump with or without pain, or if they are aged 50 and over and have symptoms of discharge, retraction or other changes of concern in one nipple only.
Other circumstances where referral should be considered include where there are skin changes that suggest breast cancer or the patient is 30 and over with an unexplained lump in the axilla. Non-urgent referrals should be considered in patients under 30 with an unexplained breast lump with or without pain.
The situation is slightly different in Scotland, where a doctor should offer a specialist referral if a patient is over 35 and has a new breast lump, a swollen lymph node in the axilla or if they are over 35 and have nodularity of the breast that does not resolve following menstruation, if they have a cyst that does not resolve, nipple changes (including blood stained discharge) or an eczema-type rash which does not respond to steroid treatment. Patients should also be referred if they are over 35 and have skin changes on the breast or inflammation in the breast which does not respond to antibiotics.
The risk of developing cancer rises as a patient gets older, with only two out of every 100 women being diagnosed with breast cancer under the age of 35, and four out of every 100 women being diagnosed with breast cancer under 40. As well as age, other risk factors for developing breast cancer include genetics (family history) and certain potentially avoidable lifestyle factors.
Oestrogen exposure is the main potentially avoidable risk factor (oral contraceptives, some forms of hormone replacement therapy, ionising radiation and diethylstilbestrol use in pregnancy), along with other risk factors such as obesity (9% of breast cancers), alcohol use (6%) and certain occupational exposures (5%). Breast feeding and physical activity are protective against breast cancer.
According to Cancer Research UK there were 55,222 new cases of invasive breast cancer in 2014 in the UK and 11,433 deaths. Five year survival is 85% and 10 year survival rates for females with breast cancer in England and Wales in 2010 to 2011 was 78%. It is thought that 27% of cases of breast cancer in the UK are preventable, being linked to major lifestyle and other risk factors.
Breast cancer is a common disease where patients have a better prognosis if they are referred to specialist services early on, and doctors need to be familiar with the referral guidelines and ensure that they apply these unless there is a good reason not to.
As part of their assessment to see whether a patient fulfils the relevant referral criteria, doctors need to take a full history and make a detailed record of this and their examination findings. This should include any relevant negative responses to questions or relevant negative examination findings.
There were a number of files where relevant information had not been recorded, and therefore it was not clear if this information had been asked. One solution may be for doctors to use a standard template when assessing patients with breast symptoms to ensure they capture all the relevant information required to make an appropriate and timely referral. While the use of a template would not be a substitute for clinical judgement, it may help to ensure that the history and examination are thorough and comprehensive.
- Consider the age of the patient and their symptoms with respect to relevant guidance.
- Arrange to review patients who have reported a lump that you have been unable to feel during examination.
- Document all of the relevant history, including family history and any risk factors.
- Document all examination findings, including relevant negative findings.
- Consider using a template for the assessment of patients with breast pathology.
- Be prepared to justify your decisions, especially if you decide not to follow the guidance.
Dr Kathryn Leask
BSc (Hons) MBChB (Hons) LLB MA MRCPCH FFFLM DMedEth
Kathryn has been a medico-legal adviser with the MDU since 2007 and is a team leader, trainer and mentor in the medical advisory department. Before joining the MDU, she worked in paediatrics gaining her MRCPCH in 2002 and did her specialty training in clinical genetics. She has an MA in Health Care Ethics and Law, a Bachelor of Law and a Professional Doctorate in Medical Ethics. She is also a fellow of the Faculty of Forensic and Legal Medicine and has previously been an examiner and Deputy Chief Examiner for the faculty exam. Kathryn is currently a member of the faculty's Training and Education Subcommittee.
See more by Dr Kathryn Leask