There is an obvious trend towards developing ambulatory procedures in gynaecology with ambulatory hysteroscopy as its mainstay. In the recent years, the fast pace of modern technological advances in gynaecologic endoscopy, and particularly in the field of hysteroscopy, have been both thrilling and spectacular. Despite this, the uptake of operative hysteroscopy in ambulatory settings has been relatively slow. There is some apprehension amongst gynaecologists to embark on therapeutic outpatient hysteroscopy, and an organisational change is required to alter the mindset. Although there are best practice guidelines for outpatient hysteroscopy, there are unresolved issues around adequate training and accreditation of future hysteroscopists. Virtual-reality simulation training for operative hysteroscopy has shown promising preliminary results, and it is being aggressively evaluated and validated. This review article is an attempt to provide a useful practical guide to all those who wish to implement ambulatory hysteroscopy services in their outpatient departments.
Introduction
Hysteroscopy is the most common gynaecological procedure used for the diagnosis and treatment of conditions associated with abnormal uterine bleeding and reproduction. Traditionally, it has been performed in a day-case setting. According to the Hospital Episode Statistics data, 42,358 diagnostic and 32,658 therapeutic hysteroscopic procedures were performed in 2012–2013 across the National Health Service (NHS) hospitals in England .
In recent years, outpatient procedures have gained more importance in gynaecology and gynaecological surgery. ‘Ambulatory hysteroscopy’ (AH) is a term used synonymously with outpatient hysteroscopy (OPH) where the entire procedure is carried out in a clinic setting without the use of general or regional anaesthesia.
There is good evidence to suggest that hysteroscopy in an ambulatory setting is preferable for the patient, and that it avoids complications, allows a quicker recovery time and lowers cost . Advances in technology have led to miniaturisation of high-definition hysteroscopes without compromising optical performance, thereby making hysteroscopy a simple, safe and well-tolerated office procedure. This has enabled the modern gynaecologist to offer the choice of AH to most women who require evaluation of abnormal uterine bleeding.
AH allows an efficient and accurate diagnosis of intrauterine pathology, including submucous fibroids, endometrial polyps and potential hyperplasia and cancer . In addition to diagnosis, it also enables appropriately skilled gynaecologists to institute minimally invasive therapeutic interventions to treat the diagnosed pathology simultaneously. This ‘see-and-treat’ philosophy is the essence of one-stop postmenopausal or menstrual disorder clinics enabling quicker diagnosis and concurrent treatment of the intrauterine pathology in most cases.
Over the last decade, diagnostic AH has been widely accepted by the gynaecologists in UK. This is clearly evident by the increasing numbers of these procedures now offered in an ambulatory setting. The number of diagnostic hysteroscopies performed in an outpatient setting in England has increased over threefold; from 5,104 procedures in 2003–2004 to 17,529 procedures in 2009–2010, and continue to rise (25,992 outpatient hysteroscopic procedures performed in 2012–2013) . Approximately 87% of NHS Trusts across UK offer outpatient diagnostic hysteroscopy service , although many of them do not have full facilities to offer therapeutic hysteroscopic procedures in an ambulatory setting in the hospital. In addition, very few Trusts offer such services in the community setting.
There is mounting evidence to support the use of outpatient therapeutic procedures such as removal of endometrial polyps , insertion and retrieval of intrauterine device (IUD) with lost threads, endometrial ablation and female sterilisation . The therapeutic indications for an ambulatory setting are not limited to these common procedures, and the remits of AH have extended even further with increased operator experience and technologic advancements enabling safe, effective treatment using office operative hysteroscopy . It is advisable to change from traditional care pathways to the more cost-effective, modern, innovative and patient-centred approach of ‘see-and-treat’ AH. Those hospitals neglecting such services are likely to become vulnerable to losing their gynaecology referrals to other providers that approach their Clinical Commissioning Groups (CCGs) with one-stop shops. Those already offering ambulatory hospital-based services should be encouraged to collaborate with respective CCGs with a view to extending this service closer to patients, in the community, wherever feasible.
The aim of this article is to provide practising and training gynaecologists with a systematic stepwise approach for setting up an AH service with particular focus on (a) service organisation; (b) finance; (c) infrastructure including equipment, staffing and other facilities; (d) audit; (e) teaching and training; and (f) multidisciplinary involvement. It addresses the ‘practical aspects’ of setting up such a service with several pragmatic tips particularly relevant to UK practitioners, but the general principles are applicable universally.
Service organisation
To establish a new service, it is vital to first acknowledge the driving forces behind it so as to determine the need and clinical importance of the service for the patients and also for the organisation. It is crucial to understand how to sustain an established service in anticipation of the changing political and organisational environment.
Strategic drivers for change
In the current climate of economic pressure and evolving political priorities in the United Kingdom, organisational change within NHS Trusts has become an increasing priority. The Department of Health, National Service Frameworks, the National Institute of Clinical Excellence and the Royal Colleges have published various clinical and organisational recommendations for NHS based on robust research. In 2008, the Royal College of Obstetricians and Gynaecologists (RCOG) published a report ‘Standards for Gynaecology’ to summarise the recommendations with an ultimate objective to provide an equitable and safe service with the best possible outcomes for women seeking gynaecological care . According to this report published in 2008, the following standards were put in place:
- 1)
Outpatient-based diagnostic hysteroscopy services should be available in the community and hospital settings, including operative hysteroscopic procedures for carefully selected cases.
- 2)
Hysteroscopy clinics should have in place appropriate and up-to-date equipment in line with national standards.
- 3)
There should be a dedicated one-stop menstrual bleeding clinic with diagnostic hysteroscopy and ultrasound facilities in the clinic.
These standards along with competition and government incentives in the form of best practice tariffs (BPTs) are the strategic drivers encouraging gynaecologists to race ahead to keep up with the modern times.
Clinical drivers for change
Rising elderly population, increasing co-morbidities including extreme obesity, need for quicker and accurate diagnostic tests, increasing patient expectations and increasing demand on services in gynaecology call for innovative ways of working that can deliver care in the most efficient (one-stop), safe (newer-generation treatment options) and cost-effective way (ambulatory setting) .
Change management
Change is a complex process that can have negative as well as positive outcomes, and hence this process has to take place in an efficient and effective manner. Organisational change theory suggests that, unless there is consensus across the professionals, there is little chance of successful holistic development. It is essential to bring a change in a way that is participative and sustainable rather than taking an authoritative and top-down approach. It should be acceptable to all health-care professionals involved in service delivery.
Good leaders lead by example, and practical demonstration of a skill has the most lasting impression. If you can convince your own colleagues, nurses and health-care assistants that simple diagnostic and therapeutic hysteroscopic procedures are easily accomplished in an outpatient setting without much discomfort to the patient, they will soon be your advocates promoting AH. Once the front-line staff is on board, it is much easier to bring the change across the whole organisation and deal with other obstacles such as finance and procurement.
A working example of this is the AH service at the Royal Derby Hospital: it started with one diagnostic OPH clinic per week performing just over 15% of hysteroscopic procedures in the outpatient setting in 2011 (85% were still performed as day cases under anaesthesia). By 2014, this expanded to six to seven clinics per week performing >80–85% diagnostic hysteroscopic procedures in the ambulatory setting. Sixty percent of endometrial polyps are removed in the outpatient setting, and hysteroscopic sterilisation and endometrial ablation clinics have recently been established. A stepwise approach is important to ensure the clinic staff do not feel the change is rushed ( Fig. 1 ). The key to developing an excellent service is to keep the patient at the centre of the focus at every step.
Dealing with organisational culture
It is paramount to deal with the mindset of the team, identify obstacles and overcome them. Most of the clinicians, untrained in outpatient procedures, are worried of inflicting pain on their patients. A lead clinician who is motivated, passionate and proficient in ambulatory hysteroscopic procedures will play an important role in dealing with the culture change, encouraging the staff to accept innovative ways of working, thereby leading the team by example.
Numerous research studies over the recent years have endeavoured to emphasise the notion of reducing discomfort and pain. In 2010, Ahmad et al. published a systematic review on pain relief for operative OPH, and they concluded that there was a significant reduction in the mean pain scores with the use of local anaesthetics during and within 30 min after OPH compared with placebo . Amongst the different types of local anaesthetic administration, the paracervical injection of local anaesthetic was shown to be the most effective method of reducing pain during OPH as compared with intracervical, transcervical or topical routes .
In fact, simple operative hysteroscopic procedures can be performed in the outpatient setting without any anaesthetic or analgesic agents as shown by Bettocchi et al. in an observational study of 4863 women: 71.9–93.5% of women underwent operative OPH without discomfort using the novel vaginoscopic approach. Vaginoscopy refers to the ‘no-touch’ approach to hysteroscopy where the hysteroscope is introduced into the vagina, through the cervical canal, into the cavity without any need for vaginal or cervical instrumentation. This micro-invasive technique is yet another development in AH, and it has been shown to reduce procedural pain significantly .
Service organisation
To establish a new service, it is vital to first acknowledge the driving forces behind it so as to determine the need and clinical importance of the service for the patients and also for the organisation. It is crucial to understand how to sustain an established service in anticipation of the changing political and organisational environment.
Strategic drivers for change
In the current climate of economic pressure and evolving political priorities in the United Kingdom, organisational change within NHS Trusts has become an increasing priority. The Department of Health, National Service Frameworks, the National Institute of Clinical Excellence and the Royal Colleges have published various clinical and organisational recommendations for NHS based on robust research. In 2008, the Royal College of Obstetricians and Gynaecologists (RCOG) published a report ‘Standards for Gynaecology’ to summarise the recommendations with an ultimate objective to provide an equitable and safe service with the best possible outcomes for women seeking gynaecological care . According to this report published in 2008, the following standards were put in place:
- 1)
Outpatient-based diagnostic hysteroscopy services should be available in the community and hospital settings, including operative hysteroscopic procedures for carefully selected cases.
- 2)
Hysteroscopy clinics should have in place appropriate and up-to-date equipment in line with national standards.
- 3)
There should be a dedicated one-stop menstrual bleeding clinic with diagnostic hysteroscopy and ultrasound facilities in the clinic.
These standards along with competition and government incentives in the form of best practice tariffs (BPTs) are the strategic drivers encouraging gynaecologists to race ahead to keep up with the modern times.
Clinical drivers for change
Rising elderly population, increasing co-morbidities including extreme obesity, need for quicker and accurate diagnostic tests, increasing patient expectations and increasing demand on services in gynaecology call for innovative ways of working that can deliver care in the most efficient (one-stop), safe (newer-generation treatment options) and cost-effective way (ambulatory setting) .
Change management
Change is a complex process that can have negative as well as positive outcomes, and hence this process has to take place in an efficient and effective manner. Organisational change theory suggests that, unless there is consensus across the professionals, there is little chance of successful holistic development. It is essential to bring a change in a way that is participative and sustainable rather than taking an authoritative and top-down approach. It should be acceptable to all health-care professionals involved in service delivery.
Good leaders lead by example, and practical demonstration of a skill has the most lasting impression. If you can convince your own colleagues, nurses and health-care assistants that simple diagnostic and therapeutic hysteroscopic procedures are easily accomplished in an outpatient setting without much discomfort to the patient, they will soon be your advocates promoting AH. Once the front-line staff is on board, it is much easier to bring the change across the whole organisation and deal with other obstacles such as finance and procurement.
A working example of this is the AH service at the Royal Derby Hospital: it started with one diagnostic OPH clinic per week performing just over 15% of hysteroscopic procedures in the outpatient setting in 2011 (85% were still performed as day cases under anaesthesia). By 2014, this expanded to six to seven clinics per week performing >80–85% diagnostic hysteroscopic procedures in the ambulatory setting. Sixty percent of endometrial polyps are removed in the outpatient setting, and hysteroscopic sterilisation and endometrial ablation clinics have recently been established. A stepwise approach is important to ensure the clinic staff do not feel the change is rushed ( Fig. 1 ). The key to developing an excellent service is to keep the patient at the centre of the focus at every step.
Dealing with organisational culture
It is paramount to deal with the mindset of the team, identify obstacles and overcome them. Most of the clinicians, untrained in outpatient procedures, are worried of inflicting pain on their patients. A lead clinician who is motivated, passionate and proficient in ambulatory hysteroscopic procedures will play an important role in dealing with the culture change, encouraging the staff to accept innovative ways of working, thereby leading the team by example.
Numerous research studies over the recent years have endeavoured to emphasise the notion of reducing discomfort and pain. In 2010, Ahmad et al. published a systematic review on pain relief for operative OPH, and they concluded that there was a significant reduction in the mean pain scores with the use of local anaesthetics during and within 30 min after OPH compared with placebo . Amongst the different types of local anaesthetic administration, the paracervical injection of local anaesthetic was shown to be the most effective method of reducing pain during OPH as compared with intracervical, transcervical or topical routes .
In fact, simple operative hysteroscopic procedures can be performed in the outpatient setting without any anaesthetic or analgesic agents as shown by Bettocchi et al. in an observational study of 4863 women: 71.9–93.5% of women underwent operative OPH without discomfort using the novel vaginoscopic approach. Vaginoscopy refers to the ‘no-touch’ approach to hysteroscopy where the hysteroscope is introduced into the vagina, through the cervical canal, into the cavity without any need for vaginal or cervical instrumentation. This micro-invasive technique is yet another development in AH, and it has been shown to reduce procedural pain significantly .
Sustaining the change
Issues that have particular significance in sustaining a change are as follows: the substance of the change (whether the change is central to the organisation and agreeable to the employees/stakeholders), the implementation process itself (how the change is managed and carried out) and the time given for the change to occur (including the sequence and pacing of events). The service should be adaptable to ongoing organisational and staff changes in order to sustain the change. Here are some practice points that contribute to sustaining change:
- 1)
Team Involvement: Valued staff are more likely to remain motivated. Meeting regularly with staff to identify barriers and concerns will enable continuous improvement with relevant input from front-line staff.
- 2)
Clinical Leadership: Strong clinical leadership is pivotal to bringing about a sustainable service transformation. This supports a positive culture change. The leader links the Trust executive board and front-line teams.
- 3)
Performance Management: Regular audits and patient satisfaction surveys to measure performance will show the benefits for patients, staff and organisation. This is an integral part of clinical governance.
- 4)
Adaptability: Any new service or change will only be sustainable if it is adaptable to the ongoing technological advances and organisational and staff changes.
Finance
Various studies have evaluated the cost-effectiveness of different models of OPH service in the management of abnormal uterine bleeding , and these studies have demonstrated that a one-stop see-and-treat model is the most cost-effective. With limited resources in NHS, finance is always a stumbling block to establish any new service. A robust business case is necessary to prove to the Executive Trust Board the importance and need for change in practice. Astute clinical leadership is crucial to move things forward; the department will slack in the absence of such leadership and ownership.
Most managers are well versed with writing business cases. The named lead clinician must work together with the clinical director, general manager and finance to put a strong business case together. The marketing company representatives are often experienced with costing, and they offer their expertise to clinicians to accelerate the process. Timely liaison with the procurement team in the hospital is recommended to ensure the right equipment is purchased at a best price.
Developing your business case
The following steps provide constructive help in writing a good business case:
- 1)
Outline clinical issue : Keep this short and relevant stating the facts only. Provide some robust evidence from the literature in support of the case, and compare with neighbouring units’ practice or national trends, for example, NICE (National Institute for Health and Care Excellence)/RCOG/BSGE (British Society for Gynaecological Endoscopy) guidance. Highlight benefits to the patient, and most importantly the financial benefit to the Trust from cost savings and increase in income from BPTs for the outpatient see-and-treat service.
- 2)
Describe options : Provide two or three options depending on what the business case is being developed for, for example, (1) the need to buy new hysteroscopes to offer more ambulatory procedures and (2) the need to increase staffing levels in gynaecology outpatients to facilitate increase in OPH clinics. The options should include the current situation, the proposed plan and an alternative plan if suitable. Definitive timelines of developments are crucial in developing your business case.
- 3)
Discuss the clinical pros and cons : This should be done for each option stated above giving bullet points for the advantages and disadvantages of each option.
- 4)
Cost each option : Get help from the finance manager to cost everything. This should include expenditure and income for each option, highlighting the surplus income with a proposed option and loss of income or negative deficit with the current option. This is an important step, and it needs the most detailed input regarding the cost incurred. For example, the costing for day-case polypectomy procedure should include the cost of theatre time, day-case facility, anaesthetist, theatre, recovery and ward nursing staff and assistants, cost of anaesthetic drugs, any disposable instruments, drapes and cost of surgeon. The costing for one-stop outpatient polyp treatment will include a proportionate cost of running OPH clinic, one nurse and health-care assistant, disposable equipment used and cost of surgeon.
- 5)
Conclusion : Concise and to-the-point summary to emphasise why the proposed option is the best way forward.
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