Hysterectomy is one of the most common nonobstetric procedures performed in the United States with more than 430,000 hysterectomies performed in 2010.1,2 By 1999, 11% of women between the ages of 35 and 45 years had undergone hysterectomy with an estimated annual cost of $5 billion.3 Minimally invasive hysterectomy includes vaginal hysterectomy, laparoscopic hysterectomy, and robotic hysterectomy. Costs differ by surgical approach4–6 with total abdominal hysterectomy (TAH) being the costliest approach as a result of a higher risk of complications and longer duration of hospital stay. The American College of Obstetricians and Gynecologists and the American Association of Gynecologic Laparoscopists recommended the use of vaginal or laparoscopic approaches for benign indications in 2009 and 2011.7,8
Patients undergoing minimally invasive hysterectomy tend to have a more satisfactory experience compared with those undergoing TAH procedures. Reduced perioperative complications, including surgical site infection, blood loss, pain as well as reduced need of analgesics, shorter length of stay, better cosmetic outcome, speedier recovery, and lower costs are the main benefits of minimally invasive hysterectomy over conventional TAH.7,9–12 In 2012, the University of Pittsburgh Medical Center introduced a pathway treatment algorithm for hysterectomy procedures (Fig. 1). The overarching goal of this effort was to develop an evidence-based clinical decision pathway to reduce variations in surgical care and reduce abdominal hysterectomy overuse, thereby promoting cost containment and decreasing patient morbidity. The aim of this article was to describe how clinical pathways can be developed and evaluated based on commonly accepted steps of developing evidence-based approaches to clinical practice.
MATERIALS AND METHODS
We conducted a retrospective medical record review of all hysterectomy surgeries performed for benign indications at the University of Pittsburgh Medical Center–affiliated hospitals from fiscal year 2012 to fiscal year 2014. All study procedures and data acquisitions were performed in the University of Pittsburgh Medical Center facilities. In fiscal year 2014, the University of Pittsburgh Medical Center held 61% of the medical–surgical market share in Allegheny County and 41% of the medical–surgical market share in western Pennsylvania, which covers 29 counties.13 In this time period, the University of Pittsburgh Medical Center system had more than 5,100 licensed beds and more than 5,500 affiliated physicians, including 3,500 employed by the University of Pittsburgh Medical Center.13 From fiscal year 2012 to fiscal year 2014, 6,638 noncancerous hysterectomies were performed across 14 University of Pittsburgh Medical Center-affiliated hospitals with Magee-Womens Hospital performing the majority of noncancerous hysterectomies. In addition, Magee-Womens Hospital has one of the largest gynecologic surgery residency programs in western Pennsylvania with approximately 40 residents in training and 30 fellows enrolled in nine different fellowships.
Our hysterectomy pathway was developed by following five steps: 1) cost and quality analysis; 2) pathway definition; 3) physician engagement; 4) electronic medical record pathway integration; and 5) evaluation of performance. During the process of pathway development, we followed the well-recognized steps of developing evidence-based practice guidelines (Box 1),14 specifically focusing on the evaluation of performance. Implementation of the pathway started in 2012; therefore, we collected data from fiscal year 2012 to fiscal year 2014. Once exempt status was obtained from the University of Pittsburgh internal review board (no human subject involvement, internal review board #PRO15030115), study data were obtained from various sources within the University of Pittsburgh Medical Center system, including: 1) Medipac (HBO Corporation, Atlanta, Georgia) for volume and procedure information; 2) EpicCare (Epic Systems, Verona, Wisconsin) for pathway specific information; and 3) Crimson (The Advisory Board Company, Austin, Texas), Cerner (Cerner Corporation, Kansas City, Missouri), and Medipac (HBO Corporation, Atlanta, Georgia) for quality of care information.
Box 1 Five Steps of Evidence-Based Practice Cited Here
- Translation of uncertainty to an answerable question
- Systematic retrieval of best evidence available
- Critical appraisal of evidence
- Application of results in practice
- Evaluation of performance
Data from Dawes M, Summerskill W, Glasziou P, Cartabellotta A, Martin J, Hopayian K, et al. Sicily statement on evidence-based practice. BMC Medical Education 2005;5:1–7.
From fiscal year 2012 to fiscal year 2014, eligible nonradical hysterectomy cases were identified (Fig. 2) by using the International Classification of Disease, 9th Revision codes. Discharge date for inpatient admissions and service date for outpatient admissions were used to identify cases in each fiscal year. For the purpose of this study, hysterectomy routes are defined in accordance with appropriate International Classification of Disease, 9th Revision codes (Appendix 1).
The diagnostic codes for hysterectomy were assigned as the indication of surgery for each case. Potential indications for hysterectomy were categorized into the following groups: adnexal pathology, leiomyoma, pelvic pain, postmenopausal bleeding, cervical problems, endometrial hyperplasia and polyps, menstruation problems, and pelvic organ prolapse (POP). The indications were not mutually exclusive, because sometimes one patient had more than one condition for which hysterectomy could have been recommended. Thus, more than one indication was collected and analyzed for most of the patients. After acquisition of all nonradical hysterectomy cases for fiscal year 2012 to fiscal year 2014, we excluded patients in whom malignancies have been found and patients in whom the route of hysterectomy was changed during the surgery.
Patients were divided into three groups based on their age (younger than 45, 45–60, and older than 60 years). They were also subcategorized based on the hysterectomy route (TAH, vaginal hysterectomy, laparoscopic hysterectomy, and robotic hysterectomy). The overall trends of TAH and minimally invasive hysterectomy proportions during the study period were determined. The proportion of patients undergoing each hysterectomy route was compared for each age group.
Data analyses were performed using R 3.1.2. Descriptive statistics have been used to look at overall data distribution and trends. The Cochran-Armitage test for linear trend was used to test the changes in hysterectomy route over time. Analysis of variance was used to compare the mean ages of the patients for each fiscal year. For categorical data, χ2 test or Fisher exact test has been used. All tests were two-sided and significance level was set at α=0.05.
Relative risk and its asymptotic 95% confidence intervals (CIs) were computed when comparing the relative proportion of surgery route and indication between fiscal year 2012 and fiscal year 2014. A generalized Cochran-Mantel-Haenszel test,15 which can test the association of two possibly ordered factors stratifying on other factors, was applied to test the linear trend of hysterectomy route over time controlling for the indication.
This pathway was implemented and practiced in 14 University of Pittsburgh Medical Center-affiliated hospitals. Between fiscal year 2012 to fiscal year 2014, 8,977 hysterectomies were performed for both benign and cancerous (nonmetastatic) indications at University of Pittsburgh Medical Center hospitals. All the hysterectomies for cancerous indications (2,339) as well as all the cases in which the route of hysterectomy has changed during the surgery (94) have been excluded. A total number of 6,544 patients with benign hysterectomy indications were included in this study to ensure a homogeneous study pool (Table 1). The mean age of all the participants across the 3 years was 48.6 years (standard deviation 11.69). For fiscal year 2012, the mean age of women undergoing hysterectomy was 48.9 years, for fiscal year 2013 the mean age was 48.1 years, and for fiscal year 2014 the mean age was 48.8 years (P=.048). When categorized by age groups, 40.8% of the women were younger than 45 years, 42.6% were 45–60 years, and 16.6% were older than 60 years. In the age groups of younger than 45 and 45–60 years, the laparoscopic approach was the most common procedure (51% and 45% of patients, respectively) followed by TAH (20%, 25% of patients, respectively). However, among women older than 60 years, the vaginal approach was the most common followed by the laparoscopic approach (33% and 32%, respectively) (Table 1).
Table 1 demonstrates that there was a statistically significant association (P<.001) between each hysterectomy indication and surgery route. Although adnexal pathology, leiomyoma, pelvic pain, postmenopausal bleeding, endometrial hyperplasia and polyps, cervical problems, and menstruation problems were all associated with a higher proportion of laparoscopic surgery, POP was the only indication associated with a higher proportion of the vaginal approach. In each of the 3 years, leiomyoma was the most common indication for hysterectomy (Table 2). The two most common indications for surgery in each age group were as follows: menstruation problems followed by pelvic pain for women younger than 45 years, leiomyoma followed by menstruation problems for women 45–60 years, and POP followed by leiomyoma for women older than 60 years (Fig. 3).
Overall, the relative proportion of TAH showed a steady linear decline (Cochran-Armitage test for linear trend, P<.001; Fig. 4) with a reduction of 39% (relative risk [RR] 0.61, 95% CI 0.55–0.69; Table 3) from 27.8% in fiscal year 2012 to 17% in fiscal year 2014. The relative proportion of laparoscopic hysterectomies increased linearly (Cochran-Armitage test for linear trend, P<.001; Fig. 4) from 41% in fiscal year 2012 to 48.4% in fiscal year 2014 (RR 1.18, 95% CI 1.103–1.263; Table 3). The relative proportion of robotic hysterectomies also trended upward (Cochran-Armitage test for linear trend, P=.03; Fig. 4) from 12.9% in fiscal year 2012 to 15.1% in fiscal year 2014, whereas vaginal hysterectomies showed no change from fiscal year 2012–2014 (18.3–19.5%) (Cochran-Armitage test for linear trend, P=.31; Fig. 4). Considering the fact that the surgery indication also changed over years (Table 2), the linear trend of surgery route was analyzed again by controlling for this potential confounder. After controlling for the surgery indication, the linear trend of each surgery route persisted (generalized Cochrane-Mantel-Haenszel test, P<.001).
As illustrated in Table 2 and Figure 5, tests for trend showed a statistically significant decrease in the relative proportion of hysterectomy for postmenopausal bleeding (Cochran-Armitage test for linear trend, P=.017) and POP (Cochran-Armitage test for linear trend, P<.001) and a statistically significant increase in the relative proportion of hysterectomy for cervical problems (Cochran-Armitage test for linear trend, P=.022) and endometrial hyperplasia and polyps (Cochran-Armitage test for linear trend, P=.004). Compared with fiscal year 2012, hysterectomy proportions in fiscal year 2014 declined by 24.6% (RR 0.754, CI 0.567–1.004) for postmenopausal bleeding and by 17% (RR 0.830, CI 0.736–0.937) for POP, whereas hysterectomy proportions increased by 46.5% (RR 1.465, CI 1.135–1.893) for cervical problems and by 40.9% (RR 1.409, CI 1.183–1.679) for endometrial hyperplasia and polyps (Table 4).
This study is the first to demonstrate the effectiveness of a surgical pathway to achieve a decreased proportion of abdominal hysterectomies among hysterectomies performed for benign indications. This is based on a search of the Ovid MEDLINE database from 1946 to August 2015 using keywords “hysterectomy or minimally invasive hysterectomy” and “clinical pathway or medical pathway” and restricted to English-language articles. This study demonstrates that the implementation of a hysterectomy pathway is associated with a decrease in the proportion of TAH procedures, an important step in building evidence-based practice for hysterectomy procedures. Our study shows that the proportion of minimally invasive hysterectomy procedures (total vaginal hysterectomy, laparoscopic hysterectomy, and robotic hysterectomy), collectively, has steadily risen since the introduction of the hysterectomy pathway at University of Pittsburgh Medical Center hospitals from 2012 through 2014. The change is mainly attributed to an increase in laparoscopic hysterectomy proportion, because total vaginal hysterectomy and robotic hysterectomy proportions have not changed significantly. In the same period of time, the proportion of TAH procedures has declined.
The increasing minimally invasive hysterectomy rates demonstrated in this study may potentially have a positive effect on the quality of care because previous studies have shown that minimally invasive hysterectomy is associated with a lower risk of surgical site infections.12 We will be looking at surgical site infections in our cohort in future studies when the data become available for analysis. It has been proposed that smaller surgical incisions and minimizing mechanical retraction at the surgical site may result in less local tissue and systemic stress and a better immunologic response, leading to lower rates of surgical site infections in patients undergoing minimally invasive hysterectomy.12 Previous publications suggest that operating room time for minimally invasive hysterectomy decreases to that of abdominal hysterectomy with the increasing skills, training, and experience of the surgeon.16,17
A study by Einarsson et al asked gynecologists to select the procedure of choice for themselves or their spouses. A majority of providers surveyed chose vaginal hysterectomy followed closely by laparoscopic hysterectomy, with only a small percentage choosing abdominal hysterectomy as the preferred route of hysterectomy.18 A study by Wu et al demonstrated that, of the 538,722 hysterectomies for benign disease performed in the United States in 2003, the majority were performed abdominally (66.1%) followed by the vaginal (21.8%) and laparoscopic (11.8%) routes.19 Although the study by Wu et al was conducted more than 10 years ago, many surgeons outside major academic centers still opt for TAH despite the emergence of minimally invasive approaches in the past decade.20 There appears to be some discordance between what gynecologists feel is the “best” procedure and the procedure they perform more frequently. This may be a result of training and comfort level with the procedure.18
The strength of this study is the fact that this pathway has been implemented in 14 facilities affiliated with the University of Pittsburgh Medical Center and has been used by almost 200 surgeons across western Pennsylvania. Our study population represents a diverse set of patients and health care providers, which minimizes the chance of selection bias. Moreover, the facilities assessed in this study have used a uniform data management system, which makes the data accessible, reliable, homogeneous, and easy to interpret.
One of the limitations of our study is that the study period is relatively short, which might make it difficult to draw definitive conclusions about the effects of implementing the new pathway over a longer timeframe. Additionally, it was impossible in the scope of this study to separately analyze surgery rates in teaching compared with nonteaching hospitals, because each University of Pittsburgh Medical Center surgeon performing hysterectomies typically operates in more than one facility. Another limitation of our study is the inability to look at more specific patient characteristics influencing outcomes, including body mass index, uterine size, race, and comorbidity status.
Few publications have examined the effect of clinical pathway implementation on gynecologic surgery practices.21–23 Because there is still a gap between the best research evidence and the best clinical practice,14 especially in the fields of obstetrics and gynecology, this project may have immediate implications for gynecologic care across the nation. Future studies will target longer periods of follow-up and will incorporate more quality indicators in the analysis. Implementing clinical pathways such as the one outlined in this study is a promising venue to guide us toward a better evidence-based practice and better patient care.
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2. Wright JD, Herzog TJ, Tsui J, Ananth CV, Lewin SN, Lu YS, et al.. Nationwide trends in the performance of inpatient hysterectomy in the. Obstet Gynecol 2013;122:233–41.
3. Matteson KA, Peipert JF, Hirway P, Cotter K, DiLuigi AJ, Jamshidi RM. Factors associated with increased charges for hysterectomy. Obstet Gynecol 2006;107:1057–63.
4. Dorsey JH, Holtz PM, Griffiths RI, McGrath MM, Steinberg EP. Costs and charges associated with three alternative techniques of hysterectomy. N Engl J Med 1996;335:476–82.
5. Lenihan JP Jr, Kovanda C, Cammarano C. Comparison of laparoscopic-assisted vaginal hysterectomy with traditional hysterectomy for cost-effectiveness to employers. Am J Obstet Gynecol 2004;190:1714–20.
6. Raju KS, Auld BJ. A randomised prospective study of laparoscopic vaginal hysterectomy versus 8 abdominal hysterectomy each with bilateral salpingo-oophorectomy. Br J Obstet Gynaecol 1994;101:1068–71.
7. American Association of Obstetricians and Gynecologists. ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol 2009;114:1156–8.
8. AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol 2011;18:1–3.
9. Walsh CA, Walsh SR, Tang TY, Slack M. Total abdominal hysterectomy versus total laparoscopic hysterectomy for benign disease: a meta-analysis. Eur J Obstet Gynecol Reprod Biol 2009;144:3–7.
10. Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol 2009;114:1041–8.
11. Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, et al.. Surgical approach to hysterectomy for benign gynaecological disease. The Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD003677. DOI: 10.1002/14651858.CD003677.pub4.
12. Gandaglia G, Ghani KR, Sood A, Meyers JR, Sammon JD, Schmid M, et al.. Effect of minimally invasive surgery on the risk for surgical site infections: results from the National Surgical Quality Improvement Program (NSQIP) Database. JAMA Surg 2014;149:1039–44.
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14. Dawes M, Summerskill W, Glasziou P, Cartabellotta A, Martin J, Hopayian K, et al.. Sicily statement on evidence-based practice. BMC Med Educ 2005;5:1.
15. Agresti A. Categorical data analysis. 2nd ed. Hoboken (NJ): John Wiley & Sons; 2002.
16. Wattiez A, Soriano D, Cohen SB, Nervo P, Canis M, Botchorishvili R, et al.. The learning curve of total laparoscopic hysterectomy: comparative analysis of 1647 cases. J Am Assoc Gynecol Laparosc 2002;9:339–45.
17. Schindlbeck C, Klauser K, Dian D, Janni W, Friese K. Comparison of total laparoscopic, vaginal and abdominal hysterectomy. Arch Gynecol Obstet 2008;277:331–7.
18. Einarsson JI, Matteson KA, Schulkin J, Chavan NR, Sangi-Haghpeykar H. Minimally invasive hysterectomies—a survey on attitudes and barriers among practicing gynecologists. J Minim Invasive Gynecol 2010;17:167–75.
19. Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol 2007;110:1091–5.
20. Lee J, Jennings K, Borahay MA, Rodriguez AM, Kilic GS, Snyder RR, et al.. Trends in the national distribution of laparoscopic hysterectomies from 2003 to 2010. J Minim Invasive Gynecol 2014;21:656–61.
21. Giede KC, Kieser K, Dodge J, Rosen B. Who should operate on patients with ovarian cancer? An evidence-based review. Gynecol Oncol 2005;99:447–61.
22. Salom E, Almeida Z, Mirhashemi R. Management of recurrent ovarian cancer: evidence-based decisions. Curr Opin Oncol 2002;14:519–27.
23. Ozols RF. Recurrent ovarian cancer: evidence-based treatment. J Clin Oncol 2002;20:1161–3.
International Classification of Diseases, 9th Revision, Codes Used for Including Patients (Inclusion Criteria) and Excluding Patients (Exclusion Criteria)
The following ICD-9 codes were used to identify patients who underwent hysterectomy for benign indications (inclusion criteria):
- 68.31 Laparoscopic supracervical hysterectomy
- 68.39 Other subtotal abdominal hysterectomy, NOS
- 68.41 Laparoscopic total abdominal hysterectomy
- 68.49 Other and unspecified total abdominal hysterectomy
- 68.51 Laparoscopically assisted vaginal hysterectomy
- 68.59 Other vaginal hysterectomy
- 17.41 Open robotic-assisted procedure (secondary code)
- 17.42 Laparoscopic robotic-assisted procedure (secondary code)
The following ICD-9 codes were used to identify patients who underwent hysterectomy for cancerous indications (exclusion criteria):
- 68.61 Radical hysterectomy (laparoscopic abdominal)
- 68.69 Radical hysterectomy (open abdominal)
- 68.71 Radical hysterectomy (laparoscopic vaginal)
- 68.79 Radical hysterectomy (open vaginal)
The following ICD-9 codes were used to identify patients in whom the surgery route had changes (exclusion criteria):
- V64.4 Closed surgical procedure converted to open procedure
- V64.41 Laparoscopic to open
The following ICD-9 codes were used to categorize the cases into groups:
- Adnexal pathology
- ○ 220 Benign neoplasm of ovary
- ○ 221.0 Benign neoplasm of fallopian tube and uterine ligaments
- ○ 221.8 Benign neoplasm of other specified sites of female genital organs
- Menstruation problems
- ○ 626.2 Excessive or frequent menstruation
- ○ 626.4 Irregular menstrual cycle
- ○ 626.6 Metrorrhagia
- ○ 626.8 Other disorders of menstruation and other abnormal bleeding from female genital tract
- ○ 626.9 Unspecified disorders of menstruation and other abnormal bleeding from female genital tract
- ○ 627.0 Premenopausal menorrhagia
- ○ 218.0 Submucous leiomyoma of uterus
- ○ 218.1 Intramural leiomyoma of uterus
- ○ 218.2 Subserous leiomyoma of uterus
- ○ 218.9 Leiomyoma of uterus, unspecified
- ○ 219.1 Benign neoplasm of corpus uteri
- ○ 219.8 Benign neoplasm of other specified parts of uterus
- ○ 219.9 Benign neoplasm of uterus, part unspecified
- ○ 618.00 Unspecified prolapse of vaginal walls
- ○ 618.01 Cystocele, midline
- ○ 618.04 Rectocele
- ○ 618.1 Uterine prolapse without mention of vaginal wall prolapse
- ○ 618.2 Uterovaginal prolapse, incomplete
- ○ 618.3 Uterovaginal prolapse, complete
- ○ 618.4 Uterovaginal prolapse, unspecified
- ○ 618.89 Other specified genital prolapse
- ○ 618.9 Unspecified genital prolapse
- Pelvic pain
- ○ 456.5 Pelvic varices
- ○ 617.0 Endometriosis of uterus
- ○ 617.1 Endometriosis of ovary
- ○ 617.2 Endometriosis of fallopian tube
- ○ 617.3 Endometriosis of pelvic peritoneum
- ○ 617.4 Endometriosis of rectovaginal septum and vagina
- ○ 617.5 Endometriosis of intestine
- ○ 617.8 Endometriosis of other specified sites
- ○ 617.9 Endometriosis, site unspecified
- ○ 625.3 Dysmenorrhea
- ○ 625.5 Pelvic congestion syndrome
- Endometrial hyperplasia and polyps
- ○ 621.0 Polyp of corpus uteri
- ○ 621.30 Endometrial hyperplasia, unspecified
- ○ 621.31 Simple endometrial hyperplasia without atypia 62131
- ○ 621.32 Complex endometrial hyperplasia without atypia
- ○ 621.33 Endometrial hyperplasia with atypia
- ○ 621.35 Endometrial intraepithelial neoplasia (EIN)
- Cervical problems
- ○ 219.0 Benign neoplasm of cervix uteri
- ○ 233.1 Carcinoma in situ of cervix uteri
- ○ 233.39 Carcinoma in situ, other female genital organ
- ○ 622.7 Mucous polyp of cervix
- ○ 622.10 Dysplasia of cervix, unspecified
- ○ 622.11 Mild dysplasia of cervix
- ○ 622.12 Moderate dysplasia of cervix
- ○ 795.00 Abnormal glandular Pap smear of cervix
- ○ 795.01 Pap smear of cervix with atypical squamous cells of undetermined significance (ASC-US)
- ○ 795.09 Other abnormal Pap smear of cervix and cervical HPV
- ○ 795.10 Abnormal glandular Pap smear of vagina
- Postmenopausal bleeding
- ○ 627.1 Postmenopausal bleeding
ICD-9, International Classification of Diseases, 9th Revision; NOS, not otherwise specified; HPV, human papillomavirus.