Abstract
A retrospective case-note study was undertaken to look at recorded details relating to information/advice given to women prior to or at the time of their gynaecological surgery with regard to possible effects of menopause/menopausal symptoms or advice given about hormone replacement therapy.
Keywords
Background
This audit was carried out as a part of the Advanced Training Skills Module (ATSM): Menopause, through the Royal College of Obstetricians and Gynaecologists (RCOG).
ATSM's are now integral to specialty training from the RCOG and allow a branch of obstetrics or gynaecology to be studied to a higher level in years 6 and 7. They have recently been approved for non-career grade doctors wanting to enhance their skill-mix and undertake more specialized training.
During my training, I became familiar with the in-house arrangements in other units for provision of menopause and hormone replacement therapy (HRT) advice for women who undergo gynaecological surgery. As a result, I reviewed our own arrangements to see how they were compared.
In addition, women who had had surgery were sent a postal questionnaire to assess if they were satisfied with the advice given and whether they would have preferred more information.
Method
The study was carried out at the Cumberland Infirmary, Carlisle. The notes of women undergoing surgery at the Cumberland Infirmary, Carlisle and West Cumberland Hospital, Whitehaven between January 2010 and June 2010 were reviewed.
Women aged 52 or younger who were undergoing either hysterectomy alone, or hysterectomy and removal of one or both ovaries or removal of both ovaries alone for benign pathology were selected.
The women were seen by a consultant, specialist registrar or general practice (GP) registrar at their initial clinic visit.
The entries in the notes of the initial consultation, during the stay in hospital and, if applicable, at the follow-up visit were reviewed – not all patients were seen for follow-up.
My ‘auditable standards’ were based around the practice in other units in line with recommendations from the ‘Consent advice’ from the RCOG 1 and the British Menopause Society Consensus Statement on ‘Management of Premature Menopause’. 2
The following standards were set:
Clear documentation in notes of status of patient – premenopausal, perimenopausal or postmenopausal Record in notes of an individualized discussion with the woman relating to possible consequences of the surgery on her hormonal balance Women under 45 should be offered and recommended to start HRT and then a plan made as to when to start Women aged between 45 and 50 should ‘consider’ HRT and be aware of alternative treatment options – can be immediately post-surgery or later Clear record to be sent to the general practitioner (GP) regarding:
type of surgery whether one or both ovaries are still present and if one remaining, documentation of whether right or left comment on whether HRT is advised – and type, i.e. combined or estrogen only whether HRT is to be started immediately (usually 10 days postsurgery)
A postal questionnaire was sent to all women in the study, asking for their recollection of discussions either at the first consultation or at the time of surgery or at their follow-up visit. They were asked if they recalled whether a discussion on the possible consequences of surgery on their hormonal status took place and if management or treatment options such as HRT were discussed.
Results
Case-notes review
Fifty case-notes were selected, but only 47 sets of notes were able to be accessed – two sets were unavailable and the third patient was found to have a malignancy.
The reasons for surgery were predominately menorrhagia (69%), but also included women having prophylactic bilateral oophorectomy for either an increased genetic risk or an estrogen-positive breast carcinoma (11%). In all, 4% of women had bilateral oophorectomy for endometriosis and 16% for either a pelvic mass, prolapse or pelvic pain.
The age range of women was between 38 and 52 – with an average age of 46.3 years.
From the notes it was possible to assess the woman's pre- or postmenopausal status in 91% of the notes.
Only 15 notes (32%) showed evidence of some consultation relating to change in ovarian function. This was either at one or several points in a patient's notes – either at the initial consultation or while an inpatient or at a follow-up visit or in the discharge letter to the GP.
Only six notes (13%) mentioned HRT, but five of these (11% of total) were in the women having surgery because of an increased cancer risk, i.e. breast cancer patients or women with increased genetic risk. All these women had documentation that HRT would not be advised. In other words if these cases are excluded there was only documentation in one out of 42 cases (2.3%) of any discussion relating to HRT (this was a woman aged 39).
In the subgroup of women aged 45 or under, there were 20 women and in 13 notes (65%) there was a mention of hormonal effect of surgery.
However, on excluding the group mentioned above who were advised not to take HRT, then HRT was only mentioned in one out of 15 case-notes for women aged 45 or under – only 7%.
In all, 45 out of 47 notes (96%) had evidence in the notes of a postsurgery letter to the GP. All contained information related to the operation but only three (6%) mentioned HRT – interestingly all were from the nurse practitioners.
Patient questionnaire
A simple tick-box questionnaire was sent to all 47 women and a return stamped envelope was enclosed. Twenty-seven responded (57%). Over half (64%) said they received some information regarding hormonal changes or HRT.
Eighteen (66%) stated that they would have liked to receive more information.
Discussion
The medical record should form a clear plan, which is written legibly, and provides evidence of information given to patients to allow decision-making. The risks and benefits of surgery needs to be discussed with women prior to their surgery.
This audit was looking at ‘documented’ evidence and this gives a very limited view of the consultation and certainly cannot convey the full advice imparted verbally.
However, in a climate of ever increasing medicolegal medicine, where the recorded information becomes the backbone of evidence, full and careful documentation becomes paramount.
Current guidance about informed consent 3 is that the patient ought to know about the procedures involved in any treatment she agrees to undergo and has a right to be involved in decisions about her care. The risk of procedure and the likelihood of complications or consequences need to be explained to the woman in a way that she can understand. The potential benefit of surgery needs to be explained and measured against the patient's expectation. Information needs to be given prior to the operation so that she has time to consider her decision. The patient information leaflet given should contain information on indication and potential risks of the proposed surgery. The type of information leaflet given should be recorded in the notes. Although increasingly patients are expected to be involved in surgical decision-making, the challenge is to assess how much the patient already knows – or indeed wants to know. Not all patients want information forced upon them and this needs to be addressed carefully. A successful relationship between doctor and patient requires trust and respects the patient's right to make a choice. An informed decision can only be made with effective communication.
Hysterectomy is the commonest gynaecological operation in the UK, and the main indication and outcome measure is to remove symptoms of menstruation with improvement in quality of life.
A decision for hysterectomy, however, cannot be made in isolation and there must be a simultaneous decision about the need or benefit of removal of ovaries (or ovary) and/or cervix.
The decision to remove the ovaries at the time of hysterectomy remains a controversial subject. Many surgeons consider it to be preventive surgery – the primary prevention being of ovarian cancer. The risk of developing ovarian cancer following hysterectomy with conservation of the ovaries is however rare, between 0.1% and 0.75%. 4,5
Prognosis in ovarian cancer remains poor as more than 70% of women present with stage III/IV disease 6 and there is currently no proven screening programme for ovarian cancer that effectively reduces mortality. Observational studies, however, suggest that bilateral oophorectomy may do more harm than good, and has not been shown to improve survival age.
Many authorities point towards retaining the ovaries in their guidance. The RCOG guidance 7 is that healthy ovaries should ‘not be routinely removed at the time of hysterectomy’. The guidance from The American College of Obstetricians and Gynaecologists 8 is ‘to retain ovaries in premenopausal women who are not at increased genetic risk of ovarian cancer and to consider removal in postmenopausal women’.
What are the risks and are we able to ‘individualize’?
Most women having a hysterectomy for benign disease will have an ‘average risk’ of developing ovarian cancer. In the UK this is a lifetime risk of 2%. Risk factors include family history, especially those with a genetic mutation (BRCA1 and BRCA2 carriers), early menarche, late menopause, low parity, subfertility, previous breast cancer and obesity.
The age of the woman at the time of surgery clearly needs to be considered primarily in the decision for or against oophorectomy. The younger the woman, the more reason there is to retain her ovaries. The older the woman, the more the balance may change but there can be no definitive age at which an oophorectomy is recommended.
Should the reason for surgery be a guide as to whether to remove the ovaries?
Obviously, if the surgery is because of suspected pathology then it may be more appropriate to remove both ovaries.
Some surgeons consider oophorectomy as secondary prevention in that it reduces the need for future ovarian surgery. The overall risk of re-operation for a gynaecological indication following a hysterectomy is low at between 0.89% and 5%. 9,10 The risk has been shown to be higher in women having initial surgery for endometriosis, pelvic pain and infection. Re-operation is recognized to have higher complication rates. In addition, concurrent medical co-morbidities, including morbid obesity, may need to be considered as balancing the risks of bilateral oophorectomy at initial surgery versus the potential of an increased risk of repeat surgery.
Women undergoing hysterectomy, with planned conservation of the ovaries, need to give consent for removal of one or both ovaries in case of the unexpected finding of pathology.
For many women, the consequence of surgery on their hormonal balance will be their main concern. The short- and long-term effects of oophorectomy need to be understood as there is an effect on a woman's long-term health. There is evidence that hysterectomy alone can reduce ovarian function possibly as a result of damage to ovarian vessels. 11
The average age of the menopause in the UK is approximately 52 years. A natural menopause is associated with a gradual decline in ovarian function in contrast to a surgical menopause with an abrupt and profound hormonal change.
The short-term effects of sudden estrogen withdrawal can be very dramatic causing immediate severe vasomotor menopausal symptoms and if HRT is chosen, may require higher doses of estrogen and have greater difficulty discontinuing therapy.
The longer-term effects of an early menopause are increased risks of osteoporosis and cardiovascular disease, and studies have shown a reduced mortality of up to two years in women with premature ovarian failure. 12 A recent large study shows that hysterectomy alone in women under 50 is associated with a raised cardiovascular risk. 13
In addition, bilateral oophorectomy before the onset of menopause has been shown to increase the risk of Parkinsonism, cognitive impairment and dementia, 14,15 and at any age significantly increases the risk of lung cancer. Perhaps a woman with a strong family history of dementia, who has seen firsthand the devastation and consequences of the disease, may wish to consider this before she consents to oophorectomy.
Further, gynaecological surgery may have an effect on sexual health, which is of great importance to all ages, with more women wanting to remain sexually active as they reach middle or older age. The ovary is a complex metabolic organ producing estrogens and androgens and their precursors. Estrogen levels decrease at the time of a natural menopause, but androgen decline is later and more gradual, reducing by about two-thirds by the early 60s. Therefore, the postmenopausal ovary remains an important source of endogenous androgens, which are intricately linked to sexual health. Oophorectomy significantly reduces this source of androgens. Female sexual dysfunction is complex and poor self-image can be enhanced by a surgical menopause, thought in part to be due to androgen deficiency, combined with estrogen deficiency.
What about HRT and its use after surgery?
Over the past nine years, since the publication of the Women's Health Initiative and the Million Women Study from 2002 and 2003, women and doctors have become less keen to consider HRT. Many women have already ‘made up their mind’ and do not want to use HRT and, even in women who choose to use HRT, the continuation rate is low. This therefore needs to be addressed and considered in the decision process.
Increasing evidence and further analysis within these studies is, however, mounting to the long-term safety and benefits of HRT, particularly in younger women.
HRT is recommended for women below age 45 having either, a natural or a surgical menopause, because of the long-term health benefits. 16 There is no increased risk with HRT use up to the natural age of menopause. 17
Conclusion
Informed consent for hysterectomy requires a discussion with several important considerations.
General advice at the time of surgery should ideally include the importance of regular exercise, maintaining a healthy body mass index, avoidance of smoking and limiting alcohol intake.
This audit has clearly demonstrated that in our unit more information should be documented, and possibly provided, to women who are undergoing gynaecological surgery regarding the possible effects of menopause, menopausal symptoms and advice about HRT. As a result of this finding, we plan to find ways to provide more consistent and comprehensive advice to women undergoing surgery. A patient information leaflet is being compiled as well as a standard proforma, which can be used at the initial consultation to capture the relevant information and act as a prompt for discussion. In addition, a more comprehensive discharge letter has been compiled to provide a full and detailed summary.
It is unlikely that these audit findings apply only to this unit. Health professionals involved with the care of women undergoing gynaecological surgery should take care to provide accurate, relevant information in clinics, while in hospital and thereafter in primary care.
We owe it to our patients to look to their future with them and help them achieve the best possible health for themselves.