Hysteroscopy involves both diagnostic and therapeutic procedures. Inpatient hysteroscopy is well established, but the development of outpatient services is relatively new. Audit is the process by which we assess a service against recognised standards; data collection enables us to perform an audit; clinical governance provides the framework for safe and effective patient care.
Hysteroscopy involves both diagnostic and therapeutic procedures. Inpatient hysteroscopy is well established, but the development of outpatient services is relatively new. Audit is the process by which we assess a service against recognised standards; data collection enables us to perform an audit; clinical governance provides the framework for safe and effective patient care. The introduction of innovative hysteroscopic devices increases the therapeutic options available to patients, but needs to be done in the context of good clinical governance, so ensuring they are used safely and effectively. This chapter gives an overview of the processes of audit, data collection and clinical governance relevant to all hysteroscopic procedures wherever performed, to help ensure safe and effective delivery of a high standard of care to patients.
As with any procedure, it is important that the hysteroscopist is adequately trained; subsequently, it is necessary to ensure that competence is maintained. This is reflected by the outcome of audits, involving the collection of procedural data and ensuring that clinical governance principles are followed. Audit is a process that not only monitors the service provided against defined standards, but when performed well leads to improvements in the care provided to patients. It is the cornerstone of clinical governance and is an important part of any clinical practice.
Florence Nightingale undertook the first clinical audit during the Crimean War (1853–1855). She collected statistics from Crimean hospitals about deaths of soldiers and showed that many were not due to wounds obtained in battle but due to diseases, exacerbated by poor sanitation. She developed diagrams to illustrate the information in order to draw the attention of the members of parliament to her concerns . As a consequence, money was made available to improve the hospital conditions with a subsequent fall in the death rates of soldiers.
One of the first medical auditors was Ernest Codman in 1912, who kept records of all his surgical outcomes . His methodology for audit was clinically based, whereas Nightingale’s approach was more epidemiological. Codman looked at quality indicators and monitoring with accountability of care. His work led to more appropriate allocation and management of resources.
Very familiar to all obstetricians and gynaecologists is the triennial national confidential enquiry into all direct and indirect maternal deaths in the UK, now continued annually by MMBRACE-UK . This commenced in 1952 with investigation of maternal deaths in England and Wales and, apart from a brief interlude, has continued since, offering an understanding of how and why deaths occurred and, importantly, recommendations to improve maternal care. However, the routine practice of audit was not taken up for many years until about 1989 when the Department of Health’s white paper saw audit integrated into the realms of routine healthcare .
The definition of audit by the UK Department of Health is the systematic critical analysis of the quality of clinical care. It includes reviewing the procedures undertaken for diagnosis and treatment, the use of resources and the resulting outcome and quality of life for the patient . The National Institute for Health and Care Excellence (NICE) defines audit as a quality improvement process that seeks to improve patient care and outcomes through the systematic review of care against explicit standards and the implementation of change .
The audit cycle commences with identifying a specific topic and then a set of appropriate standards, followed by a comparison of practice to these standards. After data analysis, any deficiencies are recognised and steps are taken to improve or modify practice, with a re-audit to see if practice has improved (Figure 17.1). It is important that when an audit is undertaken, the full audit cycle is completed. Unfortunately, this does not always happen in clinical practice. A review by Gnanalingham et al. in 2001 looked at 213 audits and found that in only 24% was the cycle of re-auditing completed, with 48% audits only partially completed .
Figure 17.1 The audit cycle.
In the early nineties, the Scottish Hysteroscopy Audit Group looked at the efficacy and safety of hysteroscopic surgery undertaken by gynaecologists . Registration of cases was prospective and patients were followed up at 6 and 12 months after their surgery with a postal questionnaire. There were 978 cases registered from 13 hospitals across seven Scottish Health Boards. Of the procedures performed, 629 (65%) were endometrial resection, 314 (32%) were laser ablation and a small number (3%) were rollerball ablation. The overall complication rate was 12%, with significant complications occurring in 1% of cases. Uterine perforation was the most frequent complication and fluid absorption of over 2 l was the most frequent significant complication. There was one death, thought to be due to toxic shock syndrome with sepsis in an uncomplicated case of resection of the endometrium.
At six months follow-up, 176 women (26%) were dissatisfied with their outcome and wanted further treatment. The majority (86%) of these women had troublesome bleeding, and 14% of women had pain. The study showed that patients undergoing endometrial resection had a significantly higher chance of pain than women who had endometrial laser ablation (p = 0.02). Of the women who were satisfied with the improvement in their symptoms after six months, 66% returned to work within two weeks and 88% within four weeks. Results from such an audit provide valuable information for other healthcare professionals undertaking similar hysteroscopy procedures, and provide a standard to which practice can be compared.
Large multi-centre audits can be a useful tool for identifying infrequent complications and for capturing information when new procedures are introduced. The results can be used to improve patient safety. Such a study undertaken in the Netherlands, published in 2000, looked at the complications of hysteroscopy in 13 600 procedures undertaken in 87 hospitals . The study found that complication rates for diagnostic hysteroscopy were significantly lower (0.13%) than those for operative procedures (0.95%) (p <0.01; 95% confidence interval (CI) 0.44−1.21). The study divided the complications into those occurring during entry into the uterine cavity or due to the technique itself. Uterine perforation was the most frequent surgical complication (0.76%) and over half of these cases (18/33) were entry-related. Insertion of the hysteroscope under direct vision was therefore advocated, rather than blind cervical dilatation. Adhesiolysis was the surgical procedure associated with the highest complication rate (4.5%) when compared with other procedures such as endometrial ablation (0.8%) and polypectomy (0.4%). This information will help the healthcare professional when counselling patients, and be of use for auditing one’s own results.
A large national study undertaken in the 1990s in the UK, the MISTLETOE study, produced an understanding of complication rates for the then relatively new hysteroscopic surgical procedures for the treatment of menstrual disorders . Endometrial destruction techniques, introduced into clinical practice in the 1980s, were being undertaken in just over half of the units across the UK by the mid-1990s. The study, conducted over 12 months across 300 NHS and independent hospitals in the UK, involved 10 686 women, and revealed the type of procedures being undertaken and where. Very few surgeons had a high caseload; 40/690 (6%) had performed more than 50 cases each, with 303/690 (44%) having done fewer than five cases. More experience performing loop resection was associated with a lower perforation rate (χ2 for trend, p <0.001). However, a combination of ablation and endometrial resection was safer than using the resection technique only (4.2% versus 6.4%; p <0.00005; 95% CI 1.2−3.2). Laser and rollerball ablation had the least intraoperative and post-operative complications (2.7% and 2.1% respectively). Two of the 10 deaths reported were directly related to the operative procedure; one due to sepsis and the other due to brainstem coning with a malignant glioma (direct death rate 2:10 000).
National audits can give healthcare providers and commissioners useful information, as demonstrated by the National Heavy Menstrual Bleeding Audit that started in 2010. The first report was published in 2011 by the Royal College of Obstetricians and Gynaecologists (RCOG) . It looked at the experiences and outcomes of women presenting to secondary care with heavy menstrual bleeding and was undertaken because of concern about the large variation in treatment services available and performed throughout England and Wales. The standards used were derived from the combined NICE and RCOG guidelines for the treatment of HMB, published in 2007 .
The audit revealed that surgical treatment rates varied between Strategic Health Authorities from 70 to 255/100 000 women; the rates within primary care trusts also varied widely from 14 to 392/100 000 women. The response from the trusts was exceptional at 100%, but unfortunately this did not reflect compliance with the NICE and RCOG HMB guidelines. Although at least 80% of hospitals offered appropriate investigations for the management of HMB, only 38% had developed dedicated HMB clinics, 24% did not provide an HMB-specific information leaflet and only 30% had a locally written protocol for the care and management of women with HMB. The implication is that better organisation and compliance with the guidelines could help ensure a more consistent provision of care throughout the country.
Not all audits provide cause for concern. The National Peer Review Programme on Gynaecology Cancer Services 2012/2013  confirmed that high standards of care were met by rapid access clinics for suspected malignancy when a one-stop approach with ultrasound scanning, hysteroscopy and endometrial biopsy was undertaken.
There are many aspects of the hysteroscopy service that can be audited, and relevant standards are provided by national guidelines and large national audits. For hysteroscopy, audit topics are suggested in Standards for Gynaecology (RCOG)  (Box 17.1), the Best Practice Guideline in Outpatient Hysteroscopy (RCOG)  (Box 17.2) and the BSGE/ESGE guidelines on fluid management in operative hysteroscopy  (Box 17.3). The topics are not limited to outpatient hysteroscopy but also include inpatient procedures. The audits suggested looking at different aspects of care provided to the patient, covering processes and procedures, service organisation, including provision of patient information, aspects of the service provided and of any procedures performed, and patient satisfaction, adverse events and failure rates.
Confirm the facilities adopted for tracking equipment used for each patient
Conduct annual review of:
Inpatient and outpatient activity, including system failures and incident reporting
Long-term outcomes of various treatment options for the treatment of menstrual symptoms
Regularly monitor quality of service by the hysteroscopy team
All services should audit patient choice and uptake rates for various operative procedures combined with outcome and complication rates
Patient satisfaction with elements of the outpatient hysteroscopy service
Complications (e.g. infections, vasovagal reactions, uterine trauma) of diagnostic and operative outpatient hysteroscopy
Failure rate of diagnostic and operative outpatient hysteroscopy and reasons for failures
Rates of cervical dilatation in outpatient hysteroscopy stratified by parity and menopausal status
Standards of documentation
Use of analgesia post-procedure
Percentage of women provided with written information and asked for written consent
Proportion and type of hysteroscopic procedures exceeding recommended fluid deficits and exploration of clinical outcomes
Prevalence of fluid distention media complications and compliance with guidance presented for subsequent management
Impact of innovations to reduce fluid overload on subsequent prevalence
Assessment of the service provided from the patient perspective can be audited comprehensively by using the NHS Outpatients Questionnaire , or the more recently developed and bespoke British Society for Gynaecological Endoscopists (BSGE) Outpatient Hysteroscopy Patient Satisfaction Survey, which can be accessed from the BSGE website (www.bsge.org.uk) or from BSGE SICS (www.bsgesics.com). The BSGE survey covers aspects of patients’ experience when visiting a clinic, starting from before their appointment, to their arrival and waiting at the hospital, the hospital environment and facilities, and continues with the appointment itself including any treatment, the doctors and professionals seen, leaving the department and finally their overall impression. Patients can add details about themselves if they wish.
Other suggestions for audit directly related to performing hysteroscopy and its outcome may include the correlation between the hysteroscopy and ultrasound scan findings, especially in cases of post-menopausal bleeding, and the correlation between the hysteroscopy findings and the histopathology result.
With particular reference to the outpatient setting, specific items could be included, such as the use of the vaginoscopic approach. Pain can be evaluated using a validated pain scoring system such as the 100 mm visual analogue scale, where zero on the left of the scale is marked ‘no pain’ and 100 at the far end on the right is marked ‘worst pain imaginable’ . Scores of 70 mm and above indicate severe pain .
National data collecting bodies such as the Health and Social Care Information Centre are responsible for collecting data across the health and social care system. This includes hospital episode statistics processing inpatient, outpatient and emergency care records on all hospital activity. These datasets provide useful information about activity and trends in hospital care. However, it must be recognised that the quality of the data collected is dependent upon the accuracy of the clinical coding, which unfortunately can be unreliable.
Collection of data is a fundamental part of audit and clinical governance. Each hospital should have a robust process whereby data can be obtained collectively and for individual clinicians. This is preferably in electronic form to enable ready scrutiny and analysis of the information.
Locally run systems are required for collecting specific details about each procedure and individual clinicians’ hysteroscopic activity. Hospital electronic databases can provide certain information, such as patient demographics. More detailed procedural information collected electronically enables ready analysis, but is not always available. There are economic benefits of an electronic patient record as shown in several systematic reviews  and there are benefits with these systems when auditing or undertaking research using electronic datasets . The production of correspondence can be included in an electronic system, allowing prompt communication with the GP and also enabling the patient to have a record of the encounter.
Where electronic facilities are not yet available, a paper-based record for case history and audit purposes should be maintained. Consideration must be given as to what information is collected, regardless of how it is subsequently stored. The RCOG Standards for Gynaecology advocate that examination and treatment notes should include, as a minimum, a description of findings, the type of hysteroscope used, the distension medium and whether any complications occurred .
The WHO Surgical Safety checklist (Figure 17.2) includes important information that needs to be highlighted before undertaking any form of hysteroscopic procedure . Modification of the checklist for hysteroscopic procedures is necessary, as the requirement for ensuring that the woman is not pregnant is missing. Also not included is the result of a pregnancy test, if indicated. The date of onset of the last menstrual period, the type of contraception used and whether unprotected sexual intercourse has occurred are important questions in the sexually active pre-menopausal woman. As the onset of the menopause can be difficult to establish, a pragmatic approach is to assume that all women under 55 years of age should be questioned.
Figure 17.2 WHO Surgical Safety Checklist with the core content for England and Wales . The content of this form can be adapted for use with outpatient procedures and with the addition of a pregnancy test check.
The change in the national tariff for hysteroscopic procedures currently favours procedures performed in an outpatient setting rather than as a day or inpatient. Accurate data collection is encouraged in order to ensure that appropriate reimbursement is obtained.
In 2017, the BSGE launched an electronic surgical information collection system known as BSGE SICS. This secure, cloud-based system was developed because it was recognised that practitioners (and ultimately their patients) would benefit from access to a simple, accessible, prospective, standardised and robust operative data collection tool in gynaecological endoscopy, in order to provide:
Enhance patient safety
Reflect on practice and implement changes where necessary
Information to support for individual job appraisals and re-validation
Documentation of practice
Evidence of practice appraisal (audit)
Information to support trainees and progress through training
Documentation of practice – summary of experience
Evidence of practice appraisal (audit) informing progress through training
Information to support non-medical practitioners e.g. nurse hysteroscopists
Documentation of practice – summary of experience
Evidence of practice appraisal (audit)
Evidence to support the wider use of gynaecological endoscopic techniques
Benchmark practice by providing precise estimates of perioperative and post-operative outcomes (analysis of whole data set).
The system is accessible via www.bsge.com, where an account can be activated. BSGE SICS is also available as an app from Google Play or the Apple App Store and collects data for hysteroscopic and laparoscopic gynaecological procedures for benign disease. For hysteroscopic practice, the system can currently provide comprehensive data for the following procedures:
Hysteroscopic submucous fibroid removal
Hysteroscopic resection of endometrium
Hysteroscopic removal of retained products of conception
The system requires the practitioner to input their pre-, peri- and post-operative data, which can be done on a variety of electronic platforms: PC or Mac desktop or laptop, tablets and smartphones. The user can search for a saved procedure to edit the information if the data provided have changed or were incomplete at the time of inputting. It has been designed to be quick and easy to use between cases, using standardised closed responses in most instances from drop-down menus and auto-filled fields for the most common responses. Post-operative data (early and late) can be added subsequently, on the same day if available, or later when reviewed in clinic. Furthermore, BSGE SICS can generate standardised reports by complication rate, complexity or success, or export the entire data set to Excel as a CSV file, allowing the individual to analyse specific data fields or outcomes according to their requirements (Figure 17.3). The system is password protected, fully encrypted and uses no patient-identifiable information (names, hospital numbers, DOB etc.) to ensure the data are secure and protected.
Figure 17.3 Screenshots from the British Society of Gynaecological Endoscopy Surgical Information Collection System (a) Home page. (b) Hysteroscopic procedures available on the ‘My Hysteroscopies’ page.
In summary, BSGE SICS allows the clinician to record specific areas of surgery – or their entire practice – in a rapid, convenient and informative way. Quality assuring practice should be integral to contemporary surgical practice but needs to be practical and efficient, user-friendly and relevant to a wide range of experienced and inexperienced practitioners.
Clinical governance is the cornerstone for ensuring the provision of safe, high-quality patient care. It is defined as ‘a system through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish’ .
The UK Government introduced a statutory requirement for clinical governance to the National Health Service in England in 1997 . It was one of several changes introduced to shift the focus of healthcare institutions away from financial concerns and activity targets and towards improving the standards of clinical care. Systematic processes had to be developed for the first time to ensure that the quality of healthcare provided was of a sufficiently high standard and that this standard was not only maintained, but increased. Hospitals and clinicians became accountable to the public through this process.
Clinical governance is often understood as consisting of seven pillars (Figure 17.4) ; these are all applicable to the provision of hysteroscopic services and should now be a routine part of clinical practice. Audit has already been covered in Section 17.2; the other components of clinical governance will be described below.