Gynaecological surgery is constantly evolving. To inform practice with high-impact research, clinicians need to focus on areas of importance. Surveys of specialist members of the British Society of Gynaecological Endoscopy have revealed a range of areas for research: diagnostic performance of laparoscopies; therapeutic laparoscopies in endometriosis; laparoscopic versus hysteroscopic sterilisation; and laparoscopic surgical techniques, among others. Clinical and economic outcomes are important in evaluating effectiveness and use of surgical health technology. For studies to be valid, reliable and generalisable, they would have to be free of bias, large and multi-centred. In a time of financial constraints, it is important to encourage clinicians and trainees to participate in important research studies to improve outcomes for patients.
Introduction
Technological innovation, combined with surgical enthusiasm, has led to the rapid evolution of minimal-access gynaecological surgery. In such an ever-changing environment, however, the principles of evidence-based medicine are in danger of being overlooked. Surgical researchers need to generate evidence in a range of areas, and need to deliver high-quality data that will affect practice.
Research is the keystone in the advancement of medicine and surgery. Research into gynaecological surgery enables us to improve existing treatments and allow the innovation of new devices and surgical techniques. The other principles of modern gynaecology surgery are the roles of multidisciplinary care and the minimisation of trauma, which has been pivotal in the introduction and constant evolution of minimal-access surgery.
Task analysis of established practice shows that surgeons are expected to make a diagnosis (taking background risks into consideration) and to provide treatment (taking the prognosis into consideration). As shown in Fig. 1 , surgical research needs to address questions in the areas of aetiology, diagnosis, prognosis and therapeutic effectiveness. Economic evaluations need to be undertaken to inform guidelines. A combination of research methods, including clinical trials, systematic reviews, and decision analyses, is required. In this chapter, we provide an overview of potential areas for future research in gynaecological surgery and issues involved in meeting this challenge.
Progress in surgical science
It is now an accepted principal that surgical practice should be based on reliable and sound clinical evidence. As shown in Fig. 2 , the number of trials in our specialty are increasing, although multicentre trials have plateaued. Reviews to assess if there has been progress made in establishing the evidence base for surgical interventions in gynaecology has shown that practice seems to be benefiting from improvement in its research. Randomised-controlled trials (RCTs) are seen as the ‘gold standard’ of research, but these can be difficult to devise for surgical interventions. Trials in gynaecological surgery have improved in quality and power over time.
Randomised-controlled trials comparing surgical interventions have been associated with many problems. Recruitment of participants into surgical studies can often be challenging. Surgical trials often involve complex surgical interventions. Difficulties can arise in the methods of blinding the patient, healthcare provider and caregivers, and in developing appropriate placebo or sham interventions, depending on the type of intervention. When assessing surgical techniques, the clinicians’ skill level should be considered. A particular problem also exists in finding surgeons at a similar level of surgical skill when trialling new techniques. Participants may not wish to be treated as ‘guinea pigs’, and the idea of randomisation for a treatment that is seen as inferior or more invasive than another can act as a deterrent. Assessment of patient willingness to participate into surgical trials can be useful in assessing study feasibility. Many of these difficulties can be overcome by choosing enthusiastic clinicians and developing motivated, well-resourced research teams and networks.
Training the trainees
The Royal College of Obstetricians and Gynaecologists states that it is ‘strongly committed to academic obstetrics and gynaecology in terms of research, teaching and training.’ A recent survey of 37 specialty trainee levels in London, UK (North East Thames training programme), revealed that 41% were frustrated at the lack of opportunities to participate in research, with 76% stating a lack of time and 66% a lack of contacts or information about possible research opportunities as obstacles in research participation. The introduction of a trainee research network can create a portal within which highly motivated doctors can participate in delivering high-impact research successfully.
Trainees are also experiencing a reduction in hands-on learning. The introduction of the Mirena ® intrauterine system and other medical interventions to manage common gynaecological conditions such as menorrhagia and endometriosis, has led to fewer operations being carried out. This, combined with the increased complexity of cases associated with resistance to medical treatments and the use of endoscopic techniques necessitating high levels of manual dexterity and spatial awareness, has compromised the training opportunities for junior doctors. Trainees are resorting to practical courses or simulation training to develop surgical skills. Simulation technologies have improved dramatically over recent years, and mimic closely the ‘real-life’ surgical experience. For example, there is good concurrent validity for simulation training in laparoscopic management of ectopic pregnancies. Thus, simulation training facilitates acquisition and maintenance of surgical skills, are overcoming limitations of experience such as work-hour restrictions. The effectiveness of simulation training is becoming an increasingly popular research topic, with virtual reality simulators and ‘box-trainers’ proving successful in increasing the skills needed for proficiency-based procedures. Research into the effectiveness of surgical education will remain a high priority in the future.
Delivering multi-centre studies
Much has been written about the factors associated with success in trials. Recruitment of participants is the main reason for failure. Research collaborative networks have been shown to be effective at uniting a large number of clinicians nationally and internationally to improve recruitment and participation in research. Collaboratives are crucial in the management and delivery of clinical trials. To address the deficiency in research opportunities highlighted above, and to formally recognise the value of involving trainees in patient recruitment into clinical trials, the Katherine Twining trainee research network has been founded ktnetwork.org . This is a trainee-led research network set up by a group of London obstetrics and gynaecology trainees, with the aims of improving research literacy and promoting participation in research in women’s health by providing opportunities to learn about evidence-base medicine, generic research skills, partake in current clinical trials by recruiting patients into local studies, and gain opportunities to develop ideas for individual projects. Other methods shown to be effective at improving recruitment into clinical trials are the use of social media, which can be used to raise awareness among patient support groups, update participating centres about recruitment, and aid clinicians in their professional development. Regular collaborator catch-up teleconferences and meetings help maintain a focus on the study and allow for trouble-shooting and gathering of ideas.
Progress in surgical science
It is now an accepted principal that surgical practice should be based on reliable and sound clinical evidence. As shown in Fig. 2 , the number of trials in our specialty are increasing, although multicentre trials have plateaued. Reviews to assess if there has been progress made in establishing the evidence base for surgical interventions in gynaecology has shown that practice seems to be benefiting from improvement in its research. Randomised-controlled trials (RCTs) are seen as the ‘gold standard’ of research, but these can be difficult to devise for surgical interventions. Trials in gynaecological surgery have improved in quality and power over time.
Randomised-controlled trials comparing surgical interventions have been associated with many problems. Recruitment of participants into surgical studies can often be challenging. Surgical trials often involve complex surgical interventions. Difficulties can arise in the methods of blinding the patient, healthcare provider and caregivers, and in developing appropriate placebo or sham interventions, depending on the type of intervention. When assessing surgical techniques, the clinicians’ skill level should be considered. A particular problem also exists in finding surgeons at a similar level of surgical skill when trialling new techniques. Participants may not wish to be treated as ‘guinea pigs’, and the idea of randomisation for a treatment that is seen as inferior or more invasive than another can act as a deterrent. Assessment of patient willingness to participate into surgical trials can be useful in assessing study feasibility. Many of these difficulties can be overcome by choosing enthusiastic clinicians and developing motivated, well-resourced research teams and networks.
Training the trainees
The Royal College of Obstetricians and Gynaecologists states that it is ‘strongly committed to academic obstetrics and gynaecology in terms of research, teaching and training.’ A recent survey of 37 specialty trainee levels in London, UK (North East Thames training programme), revealed that 41% were frustrated at the lack of opportunities to participate in research, with 76% stating a lack of time and 66% a lack of contacts or information about possible research opportunities as obstacles in research participation. The introduction of a trainee research network can create a portal within which highly motivated doctors can participate in delivering high-impact research successfully.
Trainees are also experiencing a reduction in hands-on learning. The introduction of the Mirena ® intrauterine system and other medical interventions to manage common gynaecological conditions such as menorrhagia and endometriosis, has led to fewer operations being carried out. This, combined with the increased complexity of cases associated with resistance to medical treatments and the use of endoscopic techniques necessitating high levels of manual dexterity and spatial awareness, has compromised the training opportunities for junior doctors. Trainees are resorting to practical courses or simulation training to develop surgical skills. Simulation technologies have improved dramatically over recent years, and mimic closely the ‘real-life’ surgical experience. For example, there is good concurrent validity for simulation training in laparoscopic management of ectopic pregnancies. Thus, simulation training facilitates acquisition and maintenance of surgical skills, are overcoming limitations of experience such as work-hour restrictions. The effectiveness of simulation training is becoming an increasingly popular research topic, with virtual reality simulators and ‘box-trainers’ proving successful in increasing the skills needed for proficiency-based procedures. Research into the effectiveness of surgical education will remain a high priority in the future.
Delivering multi-centre studies
Much has been written about the factors associated with success in trials. Recruitment of participants is the main reason for failure. Research collaborative networks have been shown to be effective at uniting a large number of clinicians nationally and internationally to improve recruitment and participation in research. Collaboratives are crucial in the management and delivery of clinical trials. To address the deficiency in research opportunities highlighted above, and to formally recognise the value of involving trainees in patient recruitment into clinical trials, the Katherine Twining trainee research network has been founded ktnetwork.org . This is a trainee-led research network set up by a group of London obstetrics and gynaecology trainees, with the aims of improving research literacy and promoting participation in research in women’s health by providing opportunities to learn about evidence-base medicine, generic research skills, partake in current clinical trials by recruiting patients into local studies, and gain opportunities to develop ideas for individual projects. Other methods shown to be effective at improving recruitment into clinical trials are the use of social media, which can be used to raise awareness among patient support groups, update participating centres about recruitment, and aid clinicians in their professional development. Regular collaborator catch-up teleconferences and meetings help maintain a focus on the study and allow for trouble-shooting and gathering of ideas.
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