تجزیه و تحلیل به حداقل رساندن هزینه روش ساکروم لاپاروسکوپی و مش واژینال کلی

Objective The objective of the study was a cost minimization analysis of the laparoscopic sacral colpopexy (LSC) and total vaginal mesh (TVM). Study Design Primary clinical costs were derived from our randomized control trial comparing LSC and TVM and were compared using prices from privately- and publicly-conducted procedures. Womens' opportunity cost of time were added to these estimates to produce estimates of the primary economic costs of the procedures. Reoperation costs were added to estimate the economic cost per subject. Results LSC has lower mean primary clinical cost as compared with the TVM in both the public (mean difference, $1102.96; 95% confidence interval [CI], 468.52–1737.385) and private models (mean difference, $1176.68; 95% CI, 1116.85–1236.51), respectively. Mean total economic costs were significantly lower in the LSC group as compared with the TVM ($4013.07; 95% CI, 3107.77–4918.37). Labor costs were significantly greater in the LSC but were offset by lower consumable, inpatient, opportunity, and reoperation costs as compared with the TVM. Conclusion The LSC has lower economic cost than TVM.

The CMA was conducted from the societal perspective. Within the Australian health system and within this study government, (public) payment or insurance (private) payment options are available and are detailed in our model (Figure 1). We estimated the full costs of the procedures by capturing not only the financial flows associated with them, including operating room, labor costs, inpatient costs, consumable costs, and public and insurer expenditures, but also the productivity losses of the female participants in the study during their treatment and recovery. These cost categories were summed to compute the total economic costs for each procedure; however, we also present our data in disaggregated form to enable financial and other costs to be distinguished. Australia has a public, universal health insurance scheme (Medicare) that involves zero-priced treatment for Australians who are treated as public patients. Thus, public admissions are funded directly by the Australian government including all costs of the admission. The labor costs that were used in this study were calculated using data from operating room costs for all gynecological operations performed at the Royal Brisbane and Women's Hospital from July to December 2008 and were tabulated using Transition II software, the hospital's cost accounting system. Total labor costs were divided by total operating time to achieve operating labor cost per minute and were as follows: anesthetist labor, $8.06; surgeon labor (including assistant), $7.04; and theater nursing labor, $32.19. Ward costs were estimated to be $785 per inpatient day and are listed in the Figure. Consumable costs included total vaginal mesh (Gynecare Prolift; Ethicon, Somerville, NJ) and suburethral obturator tape (TVT-O Gynecare; Ethicon) in vaginal group and trocars (Applied Medical, Rancho Sante Margarita, CA) self-styled Prolene mesh (15 × 15 cm; Ethicon) and hernia tacker to secure the mesh to the sacrum (ProTack 5 mm; Tyco Healthcare, Mansfield, MA) and are detailed in the Figure. Under the no-gap private health insurance arrangements between insurers, hospitals, and practitioners, consumers are guaranteed zero copayment. Under this arrangement, the insurers reimburse the hospitals by paying a single fee that is based on the Commonwealth Medicare Benefits Scheme (CMBS) item descriptors, converted to diagnostic-related groups (DRG) using the International Statistical Classification of Disease and Health guidelines. The relevant DRG for all prolapse procedures performed vaginally and laparoscopically is N06Z and funds all operating room and ward cost excluding surgical and anesthetic medical staff. Reimbursements of the surgeon and assistant are based on CMBS descriptors and in our model are based on the no-gap rate for the largest private health insurer, Medibank Private. The relevant descriptors in the laparoscopic group include sacral colpopexy (35597), retropubic prolapse/continence surgery (377044), posterior vaginal compartment surgery (35571), and cystoscopy (36812), and the vaginal group includes combined anterior and posterior compartment repair with mesh (35577), vault suspending procedure (35568), continence tape (35599), and cystoscopy (36812). The cost of private anesthetic services are based on a unit fee including preoperative consultation (2 units), complexity of surgery (vaginal 5, laparoscopic 7 units), and 1 unit for each 15 minute block from entry to operating room until discharge to recovery. The anesthetic time in both vaginal and laparoscopic groups and public and private is calculated by adding 30 minutes to operating time defined as from knife to skin to completion of cystoscopy in our original paper.10 Medibank Private reimburses anesthetist at $32 per unit, in which units are defined per the Australian Medicare Benefits Scheme. The opportunity cost of the time taken to recover from surgery is an important source of the societal costs of these procedures. In this study, the duration of recovery is measured as the number of days following surgery that a woman was able to return to her usual activities of daily living (ADL) as defined in our original paper as the time to return to driving, shopping, and meal preparation or return to work. Unfortunately, employment status, earnings, and other economic data were not recorded for the purposes of the RCT. Thus, we are required to make an assumption about the value of time during recovery. We assume that the opportunity cost per day of recovery is reasonably approximated by average adult ordinary total earnings, as reported by the Australian Bureau of Statistics 2010. Hence, the estimated opportunity cost per recovery day is $255.13 Naturally because the mean age of women for both interventions was 63 years (SD 8.1 and 8.8 in the LSC and TVM groups, respectively), a substantial proportion of the sample is likely to be retired from the workforce. For these women, the opportunity costs of recovery may be overestimated, even if they engage in unpaid market and nonmarket (ie, household) production. Conversely, older women who are in the workforce are likely to be longer than average in tenure and to have higher-than-average earnings. For these women, the opportunity cost of recovery time is likely to be underestimated. Thus, although we use average earnings as an approximation in this study, it would be useful for future studies of this population to collect detailed work-related data, including the value of paid and unpaid work. This information would enable a more accurate measure of the opportunity cost of women's time, both at work and at leisure, to be constructed. In the study by Maher et al,10 patients were treated under both the private model at the Wesley Hospital and the public model at the Royal Brisbane Hospital. To ensure the fairest representation of economic costs, 2 models are used and are represented by the Figure. The first model (model 1) assumes that all patients are treated as public patients and the second (model 2) assumes that all patients are treated as private patients. In each, costs are presented in disaggregate as well as aggregate form. Disaggregated clinical costs included the following cost categories for public patients: surgical costs, anesthetist costs, nursing costs, ward (inpatient stay) costs, and consumables. These categories are summed to compute primary clinical costs. The opportunity costs of recovery time are added to primary clinical costs to compute the primary economic cost. To these costs, the costs of reoperations are added with disaggregations of the clinical and opportunity costs associated with them. The sum of primary economic costs and the economic costs of reoperations provides our estimate of total economic cost and our primary outcome analysis. This review should be read in conjunction with the original article describing the study methodology and the full outcomes in detail.10 In model 2, the clinical costs are presented using no-gap reimbursement rates for the relevant Medicare items and DRG-related payment. This amounts to an assumption that the opportunity cost of clinical treatment is reflected in the no-gap rates that Australia's largest private health insurer has negotiated with some hospitals and clinicians. The study protocol was approved by the institutional review board at the Royal Women's (2004067) and Wesley hospitals (200445), and written informed consent was obtained from all participants on enrollment.

In the last decade, there has been a dramatic change in continence surgery, with the suburethral tapes proving both effective and cost efficient. The engineering ethos surrounding suburethral tapes has been directly transferred to prolapse surgery with the introduction of commercial vaginal mesh kits for prolapse in 2004. The potential benefits to the community that are associated with a reduction in operating time, hospital stay, and quicker return to activities of daily living, as was achieved in continence surgery, are substantial. Given that prolapse surgery is performed nearly twice as frequently as continence surgery and has longer operating, inpatient, and recovery times, the societal and economic impact of these improvements are likely to be considerable.3 We have demonstrated that the LSC has considerably and significantly lower costs to the TVM procedure. This cost saving was achieved with cost estimates that were derived from both public payments and private fee-for-service estimates. Prior cost-effectiveness analysis of commercial vaginal prolapse mesh kits are difficult to directly compare with our work because both prior evaluations relate only to anterior compartment prolapse and found anterior commercial mesh kits not to be cost effective. Neither evaluation included opportunity or reoperation costs.16 and 17 To our knowledge no cost comparisons exist between the laparoscopic sacral colpopexy and total vaginal meshes. We previously demonstrated that open sacral colpopexy cost were significantly greater than vaginal-based sacrospinous colpopexy, and this cost was primarily related to increased length of stay and slower return to ADL in the open sacral colpopexy.18 The laparoscopic approach has seen both of these parameters reduce at the expense of increased operating time.10 The principal aim of the introduction of vaginal prolapse mesh kits has been to lower the reintervention rate because of the high objective anatomical failure rates especially associated with native tissue repairs of anterior compartment defects. This assumption has not always been vindicated in the literature. Altman et al8 reported 1 year after commercial vaginal mesh kits that despite a higher objective success rate in the mesh group that the meshes were also associated with a higher reoperation rate of 6% (11 of 186) as compared with 0.5% (1 of 175) after native tissue repair. Sokol et al19 in an RCT at 12 months after commercial vaginal mesh kits reported similar objective success rates between the mesh and nonmesh group and a higher reoperation rate of 15.65% (5 of 32) in the mesh group as compared with no reoperations in the native tissue group. Finally, Nieminen et al20 reported a reoperation rate of 24% (25 of 105) at 3 years after transvaginal mesh, which was similar to our own rate of 22%.10 This similarity of reoperations rate in the literature following transvaginal mesh further supports the generalizability of our findings. Many factors will vary between institutions, and our model affords clinicians the opportunity to enter their own variables to determine their own total economic cost. Our one-way cost analysis gives a picture of the changes required to achieve cost equivalence. A relevant example is our operating room labor costs of $47 per minute that are comparable with previous reports of $US 44-66,21 and 22 and cost equivalence is achieved only between the LSC and TVM when these costs reach $127 per minute. The finding that the mean primary clinical cost was approximately $750 lower in both the LSC and TVM in the private than the public sector may be influenced by greater teaching requirements in the public sector and also the cost of surgeon and anesthetist is estimated at no-gap fees. In reality, clinicians who operate in the private sector may charge fees that result in consumer copayments, and these would quickly serve to nullify the apparent, but small, mean cost advantage of the private over the public sector. The limitations of this study include the surgery being conducted by only 2 surgeons, which may limit the generalizability of the findings and that the cost data relating to reoperations was estimated. The analyses omitted some costs that were not collected during the RCT, including operating room preoperative and recovery staff costs. We expect these costs to be similar in both the LSC and TVM groups and, as such, to have little if any impact of the difference between 2 interventions. In conclusion, we have demonstrated that LSC is a cost-minimizing intervention for the management of vaginal vault prolapse. Further rigorous and ongoing economic evaluations of pelvic organ prolapse surgery are required.