Delivering an effective outpatient service in gynaecology. A randomised controlled trial analysing the cost of outpatient versus daycase hysteroscopy

Transcription

1 BJOG: an International Journal of Obstetrics and Gynaecology March 2004, Vol. 111, pp DOI: /j x Delivering an effective outpatient service in gynaecology. A randomised controlled trial analysing the cost of outpatient versus daycase hysteroscopy Fiona Marsh a, Christian Kremer b, Sean Duffy a, * Objective To examine the cost implications of outpatient versus daycase hysteroscopy to the National Health Service, the patient and their employer. Design and interventions Randomised controlled trial. Setting The gynaecology clinic of a large teaching hospital. Participants Ninety-seven women with abnormal uterine bleeding requiring investigation. Methods Women were randomly allocated to either outpatient or daycase hysteroscopy. They were asked to complete diaries recording expenses and time off work. The National Health Service costs were calculated for a standard outpatient and daycase hysteroscopy. Main outcome measures Costs to the National Health Service, costs to the employer, loss of income, childcare costs and travel expenses. Results The outpatient group required significantly less time off work compared with the daycase group (0.8 days vs 3.3 days), P < Of those women who lost income due to the hysteroscopy, the average loss of income was twice as much in the daycase group ( in the outpatient group vs in the daycase group). The average cost of childcare required to cover the time spent in hospital undergoing the hysteroscopy was similar in both groups, however, the number of women requiring childcare was small. Travel costs incurred by the women were 74% more in the daycase group compared with the outpatient group with an average cost of 3.46 in the outpatient group and 6.02 in the daycase group. Daycase hysteroscopy costs the National Health Service approximately more per patient, than performing an outpatient hysteroscopy. Purchasing the hysteroscopes necessary to perform an outpatient hysteroscopy is a more expensive outlay than those required for daycase hysteroscopy. However, there are so many other savings that only 38 patients need to undergo outpatient hysteroscopy (even with a 4% failure rate) rather than daycase hysteroscopy in order to recoup the extra money required to set up an outpatient hysteroscopy service. Conclusion Outpatient hysteroscopy offers many benefits over its traditional counterpart including faster recovery, less time away from work and home and cost savings to the woman and her employer and the National Health Service. Resources need to be made available to rapidly develop this service across the UK in order to better serve both patient and taxpayer. INTRODUCTION Outpatient hysteroscopy and endometrial biopsy is now an established first line investigation for abnormal uterine bleeding. Outpatient hysteroscopy has an equally high efficacy rate when compared with hysteroscopy under general anaesthesia 1 and is now replacing daycase hysteroscopy due to the many advantages it offers, not least the avoidance of general anaesthesia and its associated risks. a Academic Department of Obstetrics and Gynaecology, St James s University Hospital, Leeds, UK b Pinderfields Hospital, Wakefield, Yorkshire, UK * Correspondence: Mr S. Duffy, Academic Department of Obstetrics and Gynaecology, Level 9, Gledhow Wing, St James s University Hospital, Beckett Street, Leeds, LS9 7TF, UK. D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology Further advantages include a faster return to normal activities and less time away from home and work. 2 Women find outpatient hysteroscopy acceptable with 84% expressing satisfaction with the procedure and 78% stating that the pain from outpatient hysteroscopy is less than that experienced during menstruation. 2 The Department of Health s National Health Service plan aims to promote treatments which are shown to be clinically and cost effective and shape these treatments around the convenience and concerns of patients. 3 One of the potential benefits of outpatient hysteroscopy is the cost saving to the woman, her employer and the National Health Service. However, there are no published data on the comparative costs of outpatient versus daycase hysteroscopy in the UK. Therefore, we undertook a prospective, randomised, controlled trial analysing the costs of outpatient versus daycase hysteroscopy to the woman, her employer and the National Health Service.

2 244 F. MARSH ET AL. METHODS Ninety-seven women were recruited from the gynaecology clinic of a large UK teaching hospital. All women had abnormal uterine bleeding which required investigation (e.g. menorrhagia, intermenstrual bleeding and postmenopausal bleeding). We excluded patients who were unfit for daycase surgery and those who preferred either outpatient or daycase hysteroscopy. Local Ethical Committee approval was obtained prior to recruitment for this study. Each of the 97 women who agreed to participate was randomly allocated at the gynaecology clinic to one of the two investigations. Randomisation was achieved using sealed envelopes containing computergenerated block randomisation numbers. Randomisation and recruitment to the study (CK) were carried out independently of the clinicians who later performed the hysteroscopy and of the person who analysed the results (FM). Outpatient hysteroscopy was performed using a 3.6 mm semiflexible hysteroscope without any anaesthesia. A Pipelle endometrial biopsy was performed in 61% of patients. Following the hysteroscopy, patients left the hospital when they felt ready. Daycase hysteroscopy was performed under general anaesthesia using a standard 5 mm rigid hysteroscope. Endometrial curettings were obtained after each procedure. Once the patient was fully mobile she was discharged home. In all other aspects, the procedures were similar. Cervical dilatation was performed when necessary and carbon dioxide was the distension medium for both methods of hysteroscopy. Primary outcome measure includes cost to the woman of loss of income, travel expenses and childcare costs. Secondary outcome measure includes cost to the employer in absent days off work and cost to the National Health Service. Women were asked to complete diaries recording how many days they were off work and whether or not they lost income as a result of the hysteroscopy. Women with children documented whether they required childcare while they were undergoing the hysteroscopy and the cost of that childcare. Women also documented their travel costs and whether or not they received any travel expense claims. To calculate the costs of outpatient and daycase hysteroscopy to the National Health Service, data were collected retrospectively on the health service resources required for a standard uncomplicated hysteroscopy. These include staff salaries, operating packs, sterilisation and general anaesthetic costs (prices valid for 2003). Staff salaries included on costs (i.e. national insurance contributions) and were obtained from the hospital finance department. The costs of the drugs used for a general anaesthetic were obtained from the hospital pharmacy department. The cost of surgical equipment is detailed, however, this is a one off cost as much of that equipment (e.g. Simms speculum) can be resterilised and used for many patients. Therefore, the cost of purchasing the pack is small when analysing costs on a per patient basis. However, the costs of sterilising the operating packs differ for each procedure this information was obtained from the hospital CCSD department. The cost of purchasing the hysteroscopes used in this hospital was obtained from the manufacturer Olympus KeyMed UK and is applicable for The required sample size was estimated with reference to the anticipated rate of patient satisfaction (not cost difference) with outpatient hysteroscopy versus daycase Fig. 1. Flow diagram describing the progress of patients through the trial.

3 COST OF OUTPATIENT VERSUS DAYCASE HYSTEROSCOPY 245 Table 1. Outpatient versus daycase hysteroscopy the cost to the patient and her employer. Values are expressed as n (%), unless otherwise indicated. Days off work and loss of income Outpatient group (n ¼ 51) 95% Confidence interval Daycase group (n ¼ 46) 95% Confidence interval Mean age (years) Paid employment 41 (80) 36 (78) Mean no. of days off work No. of women who lost income 7 (17) 5 (16) Average loss of income Childcare costs No. of women with children 12 (24) 11 (24) No. of women with children who paid for childcare 3 (25) 4 (36) Average cost of childcare ( ) Travel expenses Average distance travelled (miles) Average travel expenses No. of women who claimed for travel expenses 39 (76) 38 (83) Average claim (travel and parking) 2.68 ( ) hysteroscopy. (A sample of 97 patients was used. Assuming a 90% satisfaction rate with daycase hysteroscopy, the size of this sample would give approximately 85% power of detecting a 25% difference in satisfaction rates between daycase hysteroscopy and outpatient hysteroscopy, accepting a 5% type 1 error. Analysis was by intention to treat). The returned data were then entered onto a database (Excel, Microsoft) for analysis. Statistical significance was analysed by using m 2 test. P < 0.05 was considered significant. 95% confidence intervals were also calculated. RESULTS Of the 97 women who completed the study, 53% (n ¼ 51) were allocated to the outpatient hysteroscopy group and 47% (n ¼ 46) to the daycase hysteroscopy group. Figure 1 shows a flow diagram of the progress of a patient through the phases of this randomised trial. There were two failed outpatient procedures due to cervical stenosis and patient discomfort. These two women then went on to have a daycase hysteroscopy. The extra costs incurred for these two women and their employers due to undergoing a second procedure have been added into the overall costs of the outpatient hysteroscopy group, in keeping with an intention-to-treat analysis. Both the average age of women and the number of those in paid employment were similar in each group (Table 1). However, there was a difference in the mean number of days taken off work following the hysteroscopy. Women in the daycase group were significantly more likely to require more then one day off work compared with those women undergoing daycase hysteroscopy ( P < 0.001). Similar numbers of women in both groups had lost income as a result of their time off work due to the Table 2. The cost to the NHS of purchasing and sterilising equipment. Item Daycase hysteroscopy Outpatient hysteroscopy Cost Quantity Total Quantity Total Sponge holders Littlewoods Cervical canal dilators Uterine sound Bonney forcep Currette Simms speculum Vulcellum Non toothed forceps Cuscoe Towel clip Total cost of pack Cost of hysteroscope (Prices from 4 mm rigid mm semi-flexible 5995 Olympus Key Med UK ) hysteroscope hysteroscope Cost of sterilising this pack

4 246 F. MARSH ET AL. Table 3. The cost to the NHS of a short general anaesthetic. Item Quantity Cost Venflon Tegaderm plaster Laryngeal mask Fentanyl 100 mic vial Propofo 1% 20 ml vial Ondansetron 4 mg vial Ketorolac 10 mg/ml vial White needles ml and ml syringe Isofluorane hysteroscopy (Table 1). However, the loss of income was different between the groups. Women in the daycase group were significantly more likely to lose more than 20 in income compared with those women who underwent outpatient hysteroscopy ( P < 0.001). In both groups, similar numbers of women with children paid for childcare to cover the time they were in the hospital undergoing the hysteroscopy (Table 1). We also found that the average cost of the childcare was similar in each group. The cost of travel expenses differed in each group, with the average travel costs to women in the daycase group being just over twice as much as that in the outpatient group. The number of women who claimed for travel expenses differed slightly in each group. However, regardless of whether women claimed for their travel expenses or not, there remained a marked difference between the two groups (Table 1). The main differences in costs to the National Health Service of a daycase versus outpatient hysteroscopy are the costs of pre-operative, intraoperative and post-operative medical and nursing staff, general anaesthesia (in the case of daycase hysteroscopy), theatre consumables and sterilisation. There are many other costs incurred equally for both outpatient and daycase hysteroscopy (e.g. the cost of TV monitors, light source and lead, distension medium). However, the primary aim of this study is to determine the difference in cost between the two procedures. Therefore, health service resources that apply equally to both outpatient and daycase hysteroscopy have not been costed. The total costs to the National Health Service of staff salaries required for the pre-operative waiting area, theatre and recovery were and for daycase and outpatient hysteroscopy, respectively. Table 2 shows details of the costs to the National Health Service of purchasing and sterilising the necessary equipment required for the outpatient and daycase hysteroscopy operating packs. The initial cost of purchasing the outpatient and daycase hysteroscopes is also detailed. The costs of the drugs and consumables required to undertake a short general anaesthetic are detailed in Table 3 and are based on 2003 prices. The difference in the cost of purchasing the equipment for both outpatient and daycase hysteroscopy can be calculated from Table 2. The hysteroscope used in the outpatient setting (3.1 mm flexible) is more than twice as expensive as that used in the daycase theatre (4 mm semirigid). However, the operating pack used in the daycase theatre is considerably more expensive than that used in the outpatient setting. If a hospital were to set up a hysteroscopy service, then they would need to purchase approximately 10 operating packs and 2 hysteroscopes. In the daycase setting, this would cost 10, [Op. packs ¼ ( ) þ hysteroscope ¼ (2 2460)]. In the outpatient setting it would cost 12, [Op. packs ¼ ( ) þ hysteroscope ¼ (2 5995)]. Therefore, it is initially more expensive to purchase the equipment required for an outpatient hysteroscopy service. If we assume that the equipment required to set up a hysteroscopy service lasts for 1000 patients, then we can calculate the approximate difference in cost per patient between outpatient and daycase hysteroscopy (Table 4). Therefore, assuming an outpatient hysteroscopy is successfully performed, the lower staff costs, sterilising costs and avoidance of general anaesthesia all contribute to making outpatient hysteroscopy ( ) cheaper than daycase hysteroscopy on a per patient basis (Table 4). In keeping with the intention-to-treat analysis, it is essential to calculate the added costs to the National Health Service of performing a daycase hysteroscopy after a failed outpatient hysteroscopy in order to determine the true cost of outpatient hysteroscopy. In our study, 4% of outpatient Table 4. The cost of outpatient and daycase hysteroscopy per patient. Daycase hysteroscopy Outpatient hysteroscopy Staff costs Sterilisation costs General anaesthetic costs N/A Equipment costs (includes hysteroscope and operating pack) based on the equipment being used for 1000 patients 10,408.50/1000 ¼ ,447.10/1000 ¼ Total (plus the costs which apply to both outpatient and daycase hysteroscopy) (plus the costs which apply to both outpatient and daycase hysteroscopy)

5 COST OF OUTPATIENT VERSUS DAYCASE HYSTEROSCOPY 247 Table 5. The cost of outpatient and daycase hysteroscopy per patient based on number of cases the equipment lasts for. No. of cases equipment last for Daycase hysteroscopy cost (per patient) Outpatient hysteroscopy (includes additional costs of 4% failure rate) cost (per patient) National Health Service saving if performing outpatient as opposed to daycase hysteroscopy (per patient) hysteroscopies failed and all these women went on to undergo a daycase hysteroscopy. If 4% of outpatient hysteroscopies fail, then the real cost to the National Health Service of performing an outpatient hysteroscopy is [ þ ( )]. As previously mentioned, we have not calculated the costs of services/equipment that are required equally for both outpatient and daycase hysteroscopy. These costs include secretarial time, cleaning, lighting, heating and so on, and from a per patient basis are expected to be a small percentage of the total costs shown in Table 4. DISCUSSION The advent of safe and effective daycase investigations and treatments has changed the way in which gynaecological services are delivered in this country over the last years. The Department of Health s National Health Service plan aims to further transfer inpatient care to daycase or ambulatory (outpatient) care thus reducing the length of hospital stay and shortening waiting times. 3 Gynaecological procedures performed in the outpatient setting have been shown by several studies to be highly acceptable and popular with patients. 4 In addition, outpatient and daycase hysteroscopy have been compared in a randomised, controlled trial and have been shown to be equally effective at diagnosing intrauterine pathology. 1 However, the cost to the National Health Service of hysteroscopy in the outpatient and daycase setting has never previously been calculated in the UK. Studies performed in both Australia 4 and the United States 5 have compared the cost of outpatient and daycase hysteroscopy to their health services. They both found a marked cost saving to the health service if hysteroscopy is performed in the outpatient setting. A further study by Gillespie and Nichols 6 calculated that by adopting outpatient hysteroscopy instead of inpatient dilatation and curettage, the potential reduction to the Australian national health budget is calculated to be in excess of $60,000,000. Proponents of outpatient hysteroscopy have long since argued that when compared with daycase hysteroscopy, it provides cost savings to the patient, their employer and the National Health Service. However, this is the first prospective, randomised, controlled trial that has shown such a cost saving. In this study, two of the outpatient hysteroscopies were unsuccessful and these women underwent a daycase hysteroscopy. The extra costs incurred by both the women and the National Health Service have been added into the overall costs of the outpatient group. Despite this, the overall cost savings remain markedly higher in the outpatient hysteroscopy group. Nonetheless, for the two women who underwent a repeat procedure, the additional discomfort, anxiety, time and costs to the woman and her employer are relevant. Only 16 17% of women in paid employment lost income as a result of undergoing a hysteroscopy. However, women in the daycase group lost over twice as much as those in the outpatient group. Although we did not determine the reason for this, it is most likely due to the fact that women undergoing daycase hysteroscopy require, on average, four times longer off work compared with those undergoing outpatient hysteroscopy. The majority of employed women ( > 80%) did not lose income as a result of undergoing a hysteroscopy. Therefore, many employers lost their employee s paid time because of the hysteroscopy. In our study alone, the total number of days lost to employers is nearly four times greater in the daycase hysteroscopy group compared with the outpatient group (102.3 days vs 27.2 days, respectively). However, whether a woman is in paid employment or not, the time forgone from normal activities has an important value to the woman, her family and to society. Approximately 70% of women with children did not pay for childcare. It would have been interesting to determine the reason for this as many women may rely on free childcare (i.e. from relatives or friends), to which a monetary cost cannot be placed. Travel expenses were approximately 50% greater for the daycase group compared with those who underwent outpatient hysteroscopy. This may be because women undergoing daycase hysteroscopy are often dropped off and then re-collected, thus requiring two trips to and from the hospital and two parking tickets. Whereas because outpatient hysteroscopy requires the woman to spend significantly less time in hospital, 1 many women (and their drivers) may only undertake one journey to the hospital and pay for one parking ticket. The results show that even with a 4% failure rate (two patients) for outpatient hysteroscopy, the real cost to the National Health Service of outpatient hysteroscopy is still less than half that of daycase hysteroscopy.

6 248 F. MARSH ET AL. Consequently, every time an outpatient hysteroscopy is attempted instead of a daycase hysteroscopy, the National Health Service saves ( ) Therefore, only 38 patients need to be listed for outpatient hysteroscopy in order to recoup the extra money required to set up an outpatient hysteroscopy service ( ¼ ). This figure is based on the equipment having a life expectancy of 1000 patients. Table 5 shows that although the figures vary slightly depending on the longevity of the equipment, there always remains a substantial cost saving when performing a hysteroscopy in the outpatient setting. We have audited the average number of diagnostic hysteroscopies (both outpatient and daycase) that we perform each year, in our unit (n ¼ 2700). With knowledge of the population served by the Leeds hospital and the UK population, it is estimated that approximately 230,000 diagnostic hysteroscopies are performed in the UK each year. If all these hysteroscopies were to be performed in the outpatient setting as opposed to daycases, this would save the National Health Service approximately 12.5 million per year. There are of course many units in this country that already perform outpatient hysteroscopy, however, a recent UK survey showed that 45% of gynaecology units still do not have access to outpatient hysteroscopy facilities. 7 However, 80% of consultants working in units which do not have access would like to have the outpatient hysteroscopy. 7 The reasons for the under-utilisation of this service might include a perceived lack of women who would want the service, expensive capital outlay to purchase the equipment and a lack of expertise within the unit. However, a survey of women s preferences show they would favour an outpatient hysteroscopy if given a choice between that and daycase hysteroscopy. 8 This study has shown that although there is a higher capital equipment cost when setting up the outpatient hysteroscopy service, an overall cost saving is soon seen when compared with daycase hysteroscopy. There are now many courses offering training in outpatient hysteroscopy to gynaecologists and nurse practioners. It is not a difficult procedure to teach and the learning curve is actually quite short. 9 It is also possible to perform therapeutic procedures in the outpatient setting (e.g. endometrial ablation, submucus myomectomy and polypectomy and hysteroscopic sterilisation ), negating the need for an additional appointment for treatment. Thus, the perceived problems to setting up an outpatient hysteroscopy service are probably unfounded. In view of the many advantages outpatient hysteroscopy offers and the fact that it provides cost savings to the woman, her employer and the National Health Service, it is hoped that more resources will be allocated to develop this service in the future. CONCLUSION Outpatient hysteroscopy is not only preferred by women, but offers many benefits over its traditional counterpart, including a faster speed of recovery, less time away from work and home and cost savings to the woman, her employer and the National Health Service. It is therefore recommended that resources be made available to rapidly develop this service across the UK to better serve both the patient and the taxpayer. References 1. Tahir M, Bigrigg M, Browning J, et al. A randomised controlled trial comparing transvaginal ultrasound, outpatient hysteroscopy and endometrial biopsy with inpatient hysteroscopy and curettage. Br J Obstet Gynaecol 1999;106: Kremer C, Duffy S, Moroney M. Patient satisfaction with outpatient hysteroscopy versus day case hysteroscopy: randomised controlled trial. BMJ 2000;320: The NHS Plan. Department of Health. Available: gov.uk. 4. Ferry J, Rankin L. Low cost, patient acceptable, local analgesia approach to gynaecological outpatient surgery. A review of 817 consecutive procedures. Aust N Z J Obstet Gynaecol 1994;34(4): Hidlebaugh D. A comparison of clinical outcomes and cost of office versus hospital hysteroscopy. J Am Assoc Gynaecol Laparosc 1996; 4(1): Gillespie A, Nichols A. The value of hysteroscopy. Aust N Z J Obstet Gynaecol 1994;34(10):85 87 (February). 7. Rogerson L, Duffy S. A national survey of outpatient hysteroscopy. Gynaecol Endosc 2001;10: Marsh F, Taylor L, Kremer C, Black J, Duffy S. Delivering an effective service in gynaecology an assessment of women s preference. Gynaecol Endosc 2003;11. In press. 9. Isaacson K. Office hysteroscopy: a valuable but under-utilised technique. Curr Opin Obstet Gynecol 2002;14(4): Byrd LM, Chia KV. Balloon ablation: is this an outpatient procedure? Br J Obstet Gynaecol 2002;22(2): Loffer FD. Preliminary experience with the VersaPoint bipolar resectoscope using a vaporizing electrode in a saline distending medium. J Am Assoc Gynaecol Laparosc 2000;7(4): Hart R, Magos A. Development of a novel method of female sterilization. I: The development of a novel method of hysteroscopic sterilization. J Laparoendosc Adv Surg Tech A 2002;12(5): Accepted 14 November 2003