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Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients
Journal of Pediatric Surgery xxx (2016) xxx–xxx
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients Tehsina F. Devji a,b, Arin L. Madenci c,d, Elizabeth Carpino a, Izabela C. Leahy a, Mihail Samnaliev a, Jennifer L. Dearden a, Brent R. Weil d, Christopher B. Weldon d, Joseph Cravero a,⁎ a
Department of Anesthesiology, Preoperative and Pain Medicine, Boston Children's Hospital, Boston, MA Harvard School of Dental Medicine, Boston, MA Brigham and Women's Hospital and Harvard Medical School, Boston, MA d Department of Surgery, Boston Children's Hospital and Harvard Medical School, Boston, MA b c
a r t i c l e
i n f o
Article history: Received 14 March 2016 Received in revised form 24 July 2016 Accepted 25 July 2016 Available online xxxx Key words: Time-driven activity based costing Health care value Operative care
a b s t r a c t Purpose: The current emphasis on fiscally responsible health spending in the era of the Affordable Care Act and other health care reform necessitates cost-conscious delivery of care. “Value” in health care is defined as the quality of care divided by the cost. As such, health systems optimize value by providing the most cost-effective care possible without sacrificing safety or outcomes. Elective, minimal risk surgical procedures in children may be value-enhanced by moving from an operating room (OR) to a more cost-efficient setting. The purpose of this study was to assess the safety and cost of performing the removal of implantable central venous access devices (“ports”) in locations other than the main OR. Methods: We compared port removal at three sites: 1. Main OR, 2. Satellite OR, and 3. Clinic Procedure Room. This was a mixed-methods study including a retrospective review of medical records and prospective observation/ interviewing. To calculate cost without the inherent biases of hospital charges, costs, and payments, we utilized the methodology of time-driven activity based costing. Specifically, we recorded time spent by the patient in hospital facilities and with health care personnel. This duration was then weighted with the hourly cost of each health care professional and hospital space. The Mann–Whitney U test compared time and cost across the three sites. Overall cost at each site was divided by overall cost at the referent site (Main OR) to obtain a ratio of cost savings. Results: A total of 120 patients (40 per site) were included in the analysis. Demographic and clinical factors were not significantly different between sites. No complication occurred with port removal at any site. Time of the entire care episode was significantly decreased in the Clinic (median 161 min, 95% confidence interval [CI] 134–188 min), compared to the Main OR (median 235 min, 95% confidence interval [CI] 209–251 min) or Satellite OR (median 228 min, 95% confidence interval [CI] 211–245 min). Overall cost was decreased by 25% (95% CI: 13–34%) at the Clinic and by 6% (95% CI: − 2–11%) at the Satellite OR, compared to the Main OR (referent, P b 0.01). Conclusion: In our study, port removal in the Clinic Procedure Room was not associated with increased risk of negative outcomes. Shifting port removal from the Main OR to the Clinic may result in substantial cost savings. © 2016 Elsevier Inc. All rights reserved.
Health spending in the United States is expected to rise to approximately 20% of the gross domestic product by 2021 [1]. As a result of rising costs, hospitals must streamline health care delivery in order to optimize value [2]. Pediatric patients present a special challenge to health care systems. These patients often require general anesthesia or deep sedation for many procedures that can be performed on adults while they are awake or under only minor or moderate sedation. In many institutions, the requirement for anesthesia during these cases has traditionally necessitated the use of an operating room (OR). ⁎ Corresponding author at: Department of Anesthesiology, Perioperative, & Pain Medicine, 300 Longwood Avenue, Bader 3, Boston, MA, 02115. E-mail address: [email protected] (J. Cravero).
Reconsidering the process for minor, low-risk surgical procedures in children is particularly important given the high costs of OR time and peri-operative care [3]. Implantable venous access device (“port”) removal is one such routine and low-morbidity, low-mortality procedure that may be restructured to optimize value. Ports are critical in the treatment of many serious childhood diseases as they provide vascular access for the administration of treatments such as chemotherapy, antibiotics, and blood products, as well as for frequent blood sampling [4]. Approximately 5 million overall vascular access ports are placed every year in the United States [5]. Device removal typically occurs after successful termination of treatment and involves a small incision without the need for significant dissection or fluoroscopy. Infection risk with
http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017 0022-3468/© 2016 Elsevier Inc. All rights reserved.
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
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T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
removal is minimal. As such, removal of these devices is relatively simple and can be performed in a matter of minutes in a treatment or procedure room setting as long as appropriate anesthesia is provided. The impact on outcomes and cost of shifting port removal to the non-OR setting is unknown. The purpose of this study was to assess the safety and cost of performing port removal among pediatric patient in a clinic procedure room or satellite OR setting, as compared to the main OR. We hypothesized that port removal in a clinic procedure room would require decreased time and resources compared to the same procedure performed in a hospital OR. 1. Methods We compared port removal at three sites: 1. Quaternary Center Main OR (“Main OR”), 2. Satellite Campus OR (“Satellite OR”), and 3. Clinic Procedure Room (“Clinic”). Patients under age 18 who underwent port removal following successful treatment of the underlying condition requiring insertion were included in the study. One of 19 boardcertified pediatric general surgeons performed each procedure between June 1, 2013 and June 1, 2014. Patients with chronic mechanical cardiac conditions were, by protocol, treated exclusively in the Main OR. The Clinic Procedure Room included a private intake room, an approximately 500 square foot procedure room, and a post-procedure room with two recovery beds and private bathroom. During each port removal, patients and their families received standardized surgical care, including pre- and post-operative care as per institutional protocols. Port removal involved the creation of a small incision by a pediatric general surgeon under conscious sedation or general anesthesia provided by the anesthesia service at each of the three sites. The American Society of Anesthesiologists (ASA) physical classification status, a pre-operative health status, was used as eligibility criteria. Specifically, patients with ASA scores from 1 (healthy) to 3 (controlled systemic condition) were included in the study, because such patients can suitably receive care in either hospital operative settings (Main OR and Satellite OR) or sedative clinics (Clinic). Patients with ASA scores greater than 3 were excluded. A follow-up duration of 30 days after port removal was used for assessment of adverse outcomes. This was a mixed-methods study, including a retrospective review of medical records and prospective observation and interviewing. The following demographic data were retrospectively obtained from the medical records: age, sex, primary diagnosis, height, weight, comorbidities, and ASA score. Thirty-day procedure-related complications data (including emergency treatment of bleeding, treatment of wound infection, breakage of the catheter with a retained foreign body, emergency airway management, aspiration injury, unplanned increase in level of care provided, and unplanned presentation to the emergency department or other care provider related to the procedure) were obtained retrospectively. The primary outcome was a composite outcome of any complication. To calculate an estimate of cost without the biases of hospital charges, costs, and payments [6], we utilized the methodology of Time-Driven Activity Based Costing (TDABC) [7]. Specifically, we recorded time spent by the patient in hospital facilities and with hospital personnel using process maps specified by the TDABC methodology. The duration of each clinical activity was evaluated using electronic time stamps in the medical record that tracked time spent in the various spaces (waiting area, pre-operative area, operative area and postoperative area). Each of these time estimates were weighted with the hourly cost of each health care professional involved and hospital space utilized. Time spent by the patient was obtained retrospectively from electronic timestamps. When this information was unavailable, a proxy was obtained from the median time spent during prospective observation. Patient waiting time was measured from check-in time to the time that first pre-operative vitals were taken; pre-operative stay time was measured from the time of first vitals to entry time into the
procedure room; OR time was measured as the duration of time spent in the procedure room; and post-operative time was measured as the duration of time from exiting the procedure room to patient discharge. At the Clinic, time stamps are not collected when patients transition from the waiting area to pre-operative area; thus, a proxy duration was used based on a prospectively collected median time estimate. Professional times related to the procedure were calculated using the combination of time stamps in the medical record and hospital protocol information. Time of a care episode was defined as time elapsed between registration and discharge. Costs were calculated using the time data collected and cost of the unit of service (derived from institutional accounting data). Specifically, institutional accounting data included the following elements: (1) OR or Clinic procedure room cost (includes pre-operative setup, operative space time, pre-operative space time, post-operative turnover, operative equipment, disposables and surgeon time); (2) recovery room cost (includes monitoring equipment, nursing time, and anesthesia team oversight); (3) anesthesia cost (includes total anesthesiologist team time and anesthesia setup); and (4) anesthesia and medications not included in one of the former categories. Professional time costs were assessed based on time stamps recorded in patient medical records and cost per hour for each contributing professional (Bureau of Labor Statistics). Cost measurements were based on national median income estimates that were further converted to hourly compensation rates by dividing the annual salary and benefit expenses by the number of work hours. Hospital space costs were calculated using recorded patient time in space and hospital accounting estimates of cost per hour. Overall cost at each site was divided by overall cost at the referent site (Main OR) to obtain a ratio. Under the conservative assumption of mean (±standard deviation) of $300 (±300) difference in savings per patient, 34 patients per site were calculated to confer 80% power to detect a difference between sites at the α-level of 0.05. The Mann–Whitney U test compared continuous variables across the three sites. In order to determine if any decrease in Main OR utilization was left unused (vs. filled with other procedures), a comparison of Main OR utilization during the time period before and after ports was placed in the clinic setting was performed. A P value b 0.05 was considered significant. Statistical analysis was performed using Stata (version 12.0, Stata Corporation, College Station, TX, USA).
2. Results A total of 120 patients were identified at the Main OR, Satellite OR, and Clinic (40 per site). In the entire population, median age was 9.2 years. Females accounted for 39% of the study population and 75% of the entire cohort were considered low risk surgical patients (ASA 1 or 2). The most common underlying condition warranting port placement was myelodysplasia, which afflicted 42% (n = 50) of patients. Demographic and clinical factors did not significantly differ by location (i.e. Main OR, Satellite OR, or Clinic), with the exception of chronic mechanical cardiac conditions (Table 1), which were more frequently encountered in the Main OR. The process maps illustrate the differences in median time of surgical care across the three examined institutions (Supplementary Figs. 1– 3). Cumulative activity times within each of the four phases of care (i.e. registration, pre-operative assessment, procedure, and recovery) are compared in Fig. 1. The time of a care episode (i.e. time elapsed between registration and discharge) ranged from 108 to 455 min. All 120 patients successfully underwent port removal. There were no complications related to surgery. Median time for the care episode was 235 min at the Main OR, 228 min at the Satellite OR, and 161 min at the Clinic (P b 0.001). Significant differences between the three sites were related to the time spent in specific phases of care within the hospital (Supplementary Table 1).
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx Table 1 Baseline characteristics.a, b
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Table 2 Comparison of total cost of care ratio, using Main OR as a referent. Regula Site of care
Characteristic
Main OR (N = 40)
Satellite OR (N = 40)
Clinic (N = 40)
P
Age (years) Sex Female Male ASA status I II III IV+ Race/ethnicity Non-Hispanic white Non-Hispanic black Hispanic Asian–American Primary diagnosis Carcinoma Sarcoma Myeloma Leukemia Lymphoma Other chronic condition Transplant rejection Other chronic conditions Lung or airway condition Mechanical cardiac condition Bleeding disorder Obesity
10.6 ± 5.8
8.9 ± 5.0
8.8 ± 4.9
0.252 0.571
17 (42.5) 23 (57.5)
17 (42.5) 23 (57.5)
13 (32.5) 27 (67.5) 0.069
0 (0.0) 25 (62.5) 15 (37.5) 0 (0.0)
1 (2.5) 29 (72.5) 10 (25.0) 0 (0.0)
0 (0.0) 35 (87.5) 5 (12.5) 0 (0.0)
25 (73.5) 2 (5.9) 4 (11.8) 3 (8.8)
27 (71.1) 3 (7.9) 5 (13.2) 3 (7.9)
24 (64.9) 3 (81.1) 6 (16.2) 4 (10.8)
4 (10.0) 17 (42.5) 17 (42.5) 7 (17.5) 5 (12.5) 5 (12.5) 2 (5.0)
0 (0.0) 3 (7.5) 20 (50.0) 8 (20.0) 5 (12.5) 4 (10.0) 0 (0.0)
0 (0.0) 2 (5.0) 13 (32.5) 17 (42.5) 7 (17.5) 1 (2.5) 0 (0.0)
3 (7.5) 5 (12.5) 0 (0.0) 3 (7.5)
2 (5.0) 0 (0.0) 1 (2.5) 0 (0.0)
3 (7.5) 1 (2.5) 2 (5.0) 2 (5.0)
0.992
Institution
Median
Range
95% confidence interval
Pa
Clinic Satellite OR Main OR
0.75 0.94 1.00
0.64–0.91 0.84–1.11 –
0.66–0.84 0.89–1.00 –
b0.001 0.187 Ref.
OR, operating room; Ref., referent.
between Main OR (64 min) and Satellite OR (61 min, P = 0.46). However, median surgeon time was significantly decreased at the Clinic procedure room (46 min) compared to the Main OR (64 min, P b 0.01). The time differences translated into significant cost differences across the three institutions (Table 2). As displayed in Fig. 2, overall cost was significantly decreased by 25% at the Clinic and by 6% at the Satellite OR (vs. referent Main, P b 0.01). A review of the time period before and after the initiation of the study revealed that the OR utilization remained unchanged and substantially more than 80%.
0.114
3. Discussion
0.875 0.025 0.259 0.232
ASA, American Society of Anesthesiologists physical status classification system. a Table values are mean ± standard deviation for continuous variables and number (column %) for categorical variables. b Numbers may not sum to total because of missing data, and percentages may not sum to 100% because of rounding.
Specifically, patients receiving care in the Main OR spent more time in the procedure room (56 min, 95% confidence interval [CI] 53–59 min), which represented the highest-cost space utilized in the process compared to counterpart patients at the Satellite OR (42 min, 95% CI 39–45 min, P b 0.001) and the Clinic (41 min, 95% CI 37–45 min, P b 0.001). Patients at the Clinic spent significantly less time in the pre-operative exam space compared to counterpart patients at Satellite OR (20 min vs. 69 min, P b 0.001) and Main OR (20 min vs. 74 min, P b 0.001). The intraprocedure duration ranged from 12 to 58 min, with median (95% confidence interval [CI]) times of 33 (31–35) min, 28 (26–30) min, and 30 (28–30) min for the Main OR, Satellite OR, and Clinic respectively (P = 0.16). Median surgeon time did not significantly differ
Fig. 1. Median time spent in each phase of the surgical process at each of the three sites (Main OR; Satellite OR; Clinic). OR, operating room.
The Institute of Medicine calls for a model of care that is high quality and marked by outcomes that are effective, equitable, and timely [8]. This model promotes value, defined as patient outcomes achieved per dollar expended. The importance of maximizing value is even more germane in the current era of health care cost containment. The Affordable Care Act's increasingly universal health insurance coverage has placed a commensurate responsibility on hospitals and health care systems to provide more cost-efficient quality care through value-based incentives. We postulated that performing low risk, routine procedures (that do not require a sterile room environment, rapid air turnover, or OR personnel) in a non-OR setting would further this goal. In this study of pediatric patients undergoing port removal, we found that the procedure was more cost-effective in the Clinic setting compared to the Main OR. The significant decrease in procedure time translated to a significant 25% decrease in cost. There were no significant differences in patient outcomes. Several existing publications address the topic of improving costeffectiveness of procedures. A pilot study conducted in 2005 by Catalano and colleagues investigated differences in time and charges to patients related to bone-anchored hearing aid placement among 19 adults [9].
Fig. 2. Distribution of cost among three sites of care (Main OR; Satellite OR; Clinic). The boxwhisker plot separates cost into quartiles, with the bottom line representing the 25th percentile, the middle line representing the 50th percentile and the upper line representing the 75th percentile. The bottom “whisker” represents the 5th percentile and the upper “whisker” represents the 95th percentile. OR, operating room.
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
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T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
The authors compared a traditional OR setting with an operative clinic, revealing a 50% decrease in physician time and 31% decrease in charges to patients in the clinic setting [9]. In the present study, we noted a decrease in time of care episode for port removal in the Clinic, compared with the Main OR. We believe that the underpinnings of this difference relate to a more efficient clinic model. Specifically, in the Clinic procedure room, pre-procedure patient interactions were integrated and, thus, pre-procedure discussion and peri-procedure handoffs were made more efficient. Similarly, French and colleagues used the TDABC methodology to prospectively institute process improvements in an adult pre-operative assessment center at MD Anderson Cancer Center, resulting in a 46% cost reduction in costs [10]. Most comparable to the present study, in 2007, Leblanc and colleagues performed a cost efficiency analysis of carpal tunnel surgery in an OR versus an ambulatory care setting using activity-based costing methodology. The authors noted that cost of care in the OR was four times more expensive than care provided in the ambulatory care setting [11]. A key distinction between the processes in this work by Leblanc and colleagues compared to the present study is that of an adult population and lack of anesthesia oversight. Specifically, in the setting of the carpal tunnel surgery, 73% of procedures were completed by surgeons without oversight by an anesthesia team [11]. On the other hand, in our study, anesthesia provision was consistent across clinic and OR settings, making cost comparisons more attributable to difference in location than difference in team composition. Specifically, the type of anesthesia administered did not systematically differ between sites. All sites, including the Clinic, were approved settings for general anesthesia. The anesthesiologist involved in each respective procedure was not restricted to a particular anesthetic method. While anesthetic choice may vary on a patient-to-patient basis, the anesthesia typically employed for port removal is intravenous induction followed by inhaled general anesthesia via laryngeal mask airway. In order to avoid comparing hospital charges or cost with their inherent biases, we leveraged TDABC methodology. TDABC allows for examination of procedures in different but clinically comparable settings. This method, with the construction of process maps, provides a detailed view of procedure times and allows for disaggregation of the episode of surgical care [7]. Using the granular approach of TDABC to costing procedures, the present study documented significant differences in time and cost of routine port removals at the Satellite OR and Clinic as compared to the Main OR. One important benefit of this study design is that processes and their corresponding times and costs can be compared across the same time period. Thus, independent of billing charges and reimbursement schemes, TDABC is a tool that allows hospitals to hone in on the true costs of delivering care and thus informs process changes in a systematic way. Especially in the setting of proposed economic restructuring of the American health care system (e.g. bundled payment model), TDABC analysis becomes a compelling methodology as hospitals work to optimize cost-effectiveness independent of reimbursement. For example, finding a lower cost setting for port removal would become even more crucial in the setting of bundled payments. This analysis demonstrated that the most time intensive and costly site of care was the Main OR, followed by the Satellite OR and the Clinic. The discrete activities underlying the process maps of the Main OR and the Satellite OR were identical. The Clinic procedure pathway, however, had fewer activities within the process map. This ultimately corresponded to time and cost savings, despite more intense involvement of higher-paid care personnel within each of the activities. Procedure-specific cost savings do not necessarily imply overall cost savings. For example, cost-savings was driven by decreased use of OR time; if un-used, this decreased use of OR time would not result in any cost-savings. As such, it is important to assess whether or not the removal of the cases described in this paper resulted in underutilized fixed resources in our Main OR. The OR schedule at our institution is scheduled “as needed” for the removal of port's. As such, no block time was left unused. In addition, a review of the time period before and after the initiation of the
study revealed that the OR utilization remained substantially more than 80% and was not changed. The OR management at our institution concluded that removing these cases from the Main OR allowed cases that needed to be scheduled for the Main OR to be done so with less interference. This is critical because much of the cost of the OR is in the form of capital and fixed labor. Moving procedures to a secondary location without maintaining constant scheduling of the Main OR (i.e. filling the new void in use) would result in costly externalities, as revenue would not be generated during this idle time. It was not within the scope of this study to evaluate the implications of such surgical changes on staff payment at the home institution (e.g. effect on overtime payment). Rather, we compared the overall cost of care for port removal depending on the location of the procedure. Given that the same preoperative evaluation would occur regardless of scheduled (compared to “as needed”) case status, it is unlikely that pre-operative duration would change with type of scheduling. There were important limitations to this study. Given the retrospective nature of this analysis, we were unable to control for factors such as underlying patient disease. For example, a greater proportion of patients with sarcoma underwent procedures in the Main OR, while more patients with leukemia underwent procedures in Clinic. However, this difference in underlying disease is unlikely to have caused any meaningful differences in peri-procedural approach, given the uniformity of the port removal procedure. Additionally, because of the current structure of the three sites' accounting data, pre-operative costs were embedded within the fixed and variable operative costs. Therefore, we were unable to determine the granular contribution of pre-operative time to overall cost of care. However, because the Clinic was shown to be the most cost-efficient facility, the lack of granularity likely led to a more statistically conservative comparison between the sites (i.e. bias toward the null). Likewise, turnover of the procedure room was included in the operative cost variable, thus limiting the ability to differentiate the cost implications associated with different turnover times. In all settings, the operative environment for this minor procedure was “clean” (as opposed to “sterile”). Time intervals calculated for each phase of the procedure were derived from entries within the medical record. In the Clinic setting, time stamps were not available for the period of time transition from the waiting area to pre-operative area. To account for this, an estimate based on the median time observed prospectively was employed. The magnitude of possible bias introduced from this measure was mitigated by the short time contribution of this phase of care, typically less than ten minutes. Time of discharge was likewise not clear for all patients at all sites. Therefore, the surrogate measure of time of last vitals prior to discharge was used as the discharge time. When discharge time was recorded, there was no more than a sixminute lag time between this surrogate measure and time of discharge. Finally, the hospital accounting data used to make the cost evaluations depend on the use of algorithms that estimate the average overhead and support costs of the spaces that patients occupy as they move through different phases of their surgical care. Because a micro-costing approach (i.e. detailing the specific combinations of disposables used during each different procedure) was not taken, differences in the use of disposables or medications that are not billed for were not accounted for in our analysis. However, this is considered normal variation in care delivery and would not be expected to substantially differ between sites. In conclusion, port removal was most cost-effective in settings outside of the OR with no significant difference in measurable clinical outcomes across the sites. In order to improve the value of care, institutions and providers should consider shifting elective procedures that do not require OR resources (such as routine port removals) from ORs to less resource-intensive settings such as clinic procedure or treatment rooms that are appropriately configured for such care. Future study will assess the important domain of patient satisfaction with minor procedures performed in non-OR settings. Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.jpedsurg.2016.07.017.
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
References [1] Gordon JE, Leiman JM, Deland EL, et al. Delivering value: provider efforts to improve the quality and reduce the cost of health care. Annu Rev Med 2014;65:447–58. [2] Kaplan RS, Porter ME. How to solve the cost crisis in health care. Harv Bus Rev 2011; 89:46–52 [54: 56–61 passim]. [3] Dhupar R, Evankovich J, Klune JR, et al. Delayed operating room availability significantly impacts the total hospital costs of an urgent surgical procedure. Surgery 2011;150:299–305. [4] Dillon PA, Foglia RP. Complications associated with an implantable vascular access device. J Pediatr Surg 2006;41:1582–7. [5] Knebel P, Lopez-Benitez R, Radeleff B, Fischer L, Stampfl U, Bruckner T, et al. Insertion of totally implantable venous access devices: an expertisebased, randomized, controlled trial (NCT00600444). Ann Surg 2011;253:1111–7.
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[6] Chan YC. Improving hospital cost accounting with activity-based costing. Health Care Manage Rev 1993;18:71–7. [7] Porter ME. A strategy for health care reform – toward a value-based system. N Engl J Med 2009;361:109–12. [8] Greenberg CC, Kennedy GD. Advancing quality measurement to include the patient perspective. Ann Surg 2014;260:10–2. [9] Catalano PJ, Choi E, Cohen N. Office versus operating room insertion of the boneanchored hearing aid: a comparative analysis. Otol Neurotol 2005;26:1182–5. [10] French K, Albright H, Frenzel J, Incalcaterra J, Rubio A, Jones J, Feeley T, et al. Measuring the value of process improvement initiatives in a preoperative assessment center using time-driven activity-based costing. Healthc (Amst) 2013;1:136–42. [11] Leblanc MR, Lalonde J, Lalonde DH. A detailed cost and efficiency analysis of performing carpal tunnel surgery in the main operating room versus the ambulatory setting in Canada. Hand 2007;173–178.
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients Tehsina F. Devji a,b, Arin L. Madenci c,d, Elizabeth Carpino a, Izabela C. Leahy a, Mihail Samnaliev a, Jennifer L. Dearden a, Brent R. Weil d, Christopher B. Weldon d, Joseph Cravero a,⁎ a
Department of Anesthesiology, Preoperative and Pain Medicine, Boston Children's Hospital, Boston, MA Harvard School of Dental Medicine, Boston, MA Brigham and Women's Hospital and Harvard Medical School, Boston, MA d Department of Surgery, Boston Children's Hospital and Harvard Medical School, Boston, MA b c
a r t i c l e
i n f o
Article history: Received 14 March 2016 Received in revised form 24 July 2016 Accepted 25 July 2016 Available online xxxx Key words: Time-driven activity based costing Health care value Operative care
a b s t r a c t Purpose: The current emphasis on fiscally responsible health spending in the era of the Affordable Care Act and other health care reform necessitates cost-conscious delivery of care. “Value” in health care is defined as the quality of care divided by the cost. As such, health systems optimize value by providing the most cost-effective care possible without sacrificing safety or outcomes. Elective, minimal risk surgical procedures in children may be value-enhanced by moving from an operating room (OR) to a more cost-efficient setting. The purpose of this study was to assess the safety and cost of performing the removal of implantable central venous access devices (“ports”) in locations other than the main OR. Methods: We compared port removal at three sites: 1. Main OR, 2. Satellite OR, and 3. Clinic Procedure Room. This was a mixed-methods study including a retrospective review of medical records and prospective observation/ interviewing. To calculate cost without the inherent biases of hospital charges, costs, and payments, we utilized the methodology of time-driven activity based costing. Specifically, we recorded time spent by the patient in hospital facilities and with health care personnel. This duration was then weighted with the hourly cost of each health care professional and hospital space. The Mann–Whitney U test compared time and cost across the three sites. Overall cost at each site was divided by overall cost at the referent site (Main OR) to obtain a ratio of cost savings. Results: A total of 120 patients (40 per site) were included in the analysis. Demographic and clinical factors were not significantly different between sites. No complication occurred with port removal at any site. Time of the entire care episode was significantly decreased in the Clinic (median 161 min, 95% confidence interval [CI] 134–188 min), compared to the Main OR (median 235 min, 95% confidence interval [CI] 209–251 min) or Satellite OR (median 228 min, 95% confidence interval [CI] 211–245 min). Overall cost was decreased by 25% (95% CI: 13–34%) at the Clinic and by 6% (95% CI: − 2–11%) at the Satellite OR, compared to the Main OR (referent, P b 0.01). Conclusion: In our study, port removal in the Clinic Procedure Room was not associated with increased risk of negative outcomes. Shifting port removal from the Main OR to the Clinic may result in substantial cost savings. © 2016 Elsevier Inc. All rights reserved.
Health spending in the United States is expected to rise to approximately 20% of the gross domestic product by 2021 [1]. As a result of rising costs, hospitals must streamline health care delivery in order to optimize value [2]. Pediatric patients present a special challenge to health care systems. These patients often require general anesthesia or deep sedation for many procedures that can be performed on adults while they are awake or under only minor or moderate sedation. In many institutions, the requirement for anesthesia during these cases has traditionally necessitated the use of an operating room (OR). ⁎ Corresponding author at: Department of Anesthesiology, Perioperative, & Pain Medicine, 300 Longwood Avenue, Bader 3, Boston, MA, 02115. E-mail address: [email protected] (J. Cravero).
Reconsidering the process for minor, low-risk surgical procedures in children is particularly important given the high costs of OR time and peri-operative care [3]. Implantable venous access device (“port”) removal is one such routine and low-morbidity, low-mortality procedure that may be restructured to optimize value. Ports are critical in the treatment of many serious childhood diseases as they provide vascular access for the administration of treatments such as chemotherapy, antibiotics, and blood products, as well as for frequent blood sampling [4]. Approximately 5 million overall vascular access ports are placed every year in the United States [5]. Device removal typically occurs after successful termination of treatment and involves a small incision without the need for significant dissection or fluoroscopy. Infection risk with
http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017 0022-3468/© 2016 Elsevier Inc. All rights reserved.
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
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T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
removal is minimal. As such, removal of these devices is relatively simple and can be performed in a matter of minutes in a treatment or procedure room setting as long as appropriate anesthesia is provided. The impact on outcomes and cost of shifting port removal to the non-OR setting is unknown. The purpose of this study was to assess the safety and cost of performing port removal among pediatric patient in a clinic procedure room or satellite OR setting, as compared to the main OR. We hypothesized that port removal in a clinic procedure room would require decreased time and resources compared to the same procedure performed in a hospital OR. 1. Methods We compared port removal at three sites: 1. Quaternary Center Main OR (“Main OR”), 2. Satellite Campus OR (“Satellite OR”), and 3. Clinic Procedure Room (“Clinic”). Patients under age 18 who underwent port removal following successful treatment of the underlying condition requiring insertion were included in the study. One of 19 boardcertified pediatric general surgeons performed each procedure between June 1, 2013 and June 1, 2014. Patients with chronic mechanical cardiac conditions were, by protocol, treated exclusively in the Main OR. The Clinic Procedure Room included a private intake room, an approximately 500 square foot procedure room, and a post-procedure room with two recovery beds and private bathroom. During each port removal, patients and their families received standardized surgical care, including pre- and post-operative care as per institutional protocols. Port removal involved the creation of a small incision by a pediatric general surgeon under conscious sedation or general anesthesia provided by the anesthesia service at each of the three sites. The American Society of Anesthesiologists (ASA) physical classification status, a pre-operative health status, was used as eligibility criteria. Specifically, patients with ASA scores from 1 (healthy) to 3 (controlled systemic condition) were included in the study, because such patients can suitably receive care in either hospital operative settings (Main OR and Satellite OR) or sedative clinics (Clinic). Patients with ASA scores greater than 3 were excluded. A follow-up duration of 30 days after port removal was used for assessment of adverse outcomes. This was a mixed-methods study, including a retrospective review of medical records and prospective observation and interviewing. The following demographic data were retrospectively obtained from the medical records: age, sex, primary diagnosis, height, weight, comorbidities, and ASA score. Thirty-day procedure-related complications data (including emergency treatment of bleeding, treatment of wound infection, breakage of the catheter with a retained foreign body, emergency airway management, aspiration injury, unplanned increase in level of care provided, and unplanned presentation to the emergency department or other care provider related to the procedure) were obtained retrospectively. The primary outcome was a composite outcome of any complication. To calculate an estimate of cost without the biases of hospital charges, costs, and payments [6], we utilized the methodology of Time-Driven Activity Based Costing (TDABC) [7]. Specifically, we recorded time spent by the patient in hospital facilities and with hospital personnel using process maps specified by the TDABC methodology. The duration of each clinical activity was evaluated using electronic time stamps in the medical record that tracked time spent in the various spaces (waiting area, pre-operative area, operative area and postoperative area). Each of these time estimates were weighted with the hourly cost of each health care professional involved and hospital space utilized. Time spent by the patient was obtained retrospectively from electronic timestamps. When this information was unavailable, a proxy was obtained from the median time spent during prospective observation. Patient waiting time was measured from check-in time to the time that first pre-operative vitals were taken; pre-operative stay time was measured from the time of first vitals to entry time into the
procedure room; OR time was measured as the duration of time spent in the procedure room; and post-operative time was measured as the duration of time from exiting the procedure room to patient discharge. At the Clinic, time stamps are not collected when patients transition from the waiting area to pre-operative area; thus, a proxy duration was used based on a prospectively collected median time estimate. Professional times related to the procedure were calculated using the combination of time stamps in the medical record and hospital protocol information. Time of a care episode was defined as time elapsed between registration and discharge. Costs were calculated using the time data collected and cost of the unit of service (derived from institutional accounting data). Specifically, institutional accounting data included the following elements: (1) OR or Clinic procedure room cost (includes pre-operative setup, operative space time, pre-operative space time, post-operative turnover, operative equipment, disposables and surgeon time); (2) recovery room cost (includes monitoring equipment, nursing time, and anesthesia team oversight); (3) anesthesia cost (includes total anesthesiologist team time and anesthesia setup); and (4) anesthesia and medications not included in one of the former categories. Professional time costs were assessed based on time stamps recorded in patient medical records and cost per hour for each contributing professional (Bureau of Labor Statistics). Cost measurements were based on national median income estimates that were further converted to hourly compensation rates by dividing the annual salary and benefit expenses by the number of work hours. Hospital space costs were calculated using recorded patient time in space and hospital accounting estimates of cost per hour. Overall cost at each site was divided by overall cost at the referent site (Main OR) to obtain a ratio. Under the conservative assumption of mean (±standard deviation) of $300 (±300) difference in savings per patient, 34 patients per site were calculated to confer 80% power to detect a difference between sites at the α-level of 0.05. The Mann–Whitney U test compared continuous variables across the three sites. In order to determine if any decrease in Main OR utilization was left unused (vs. filled with other procedures), a comparison of Main OR utilization during the time period before and after ports was placed in the clinic setting was performed. A P value b 0.05 was considered significant. Statistical analysis was performed using Stata (version 12.0, Stata Corporation, College Station, TX, USA).
2. Results A total of 120 patients were identified at the Main OR, Satellite OR, and Clinic (40 per site). In the entire population, median age was 9.2 years. Females accounted for 39% of the study population and 75% of the entire cohort were considered low risk surgical patients (ASA 1 or 2). The most common underlying condition warranting port placement was myelodysplasia, which afflicted 42% (n = 50) of patients. Demographic and clinical factors did not significantly differ by location (i.e. Main OR, Satellite OR, or Clinic), with the exception of chronic mechanical cardiac conditions (Table 1), which were more frequently encountered in the Main OR. The process maps illustrate the differences in median time of surgical care across the three examined institutions (Supplementary Figs. 1– 3). Cumulative activity times within each of the four phases of care (i.e. registration, pre-operative assessment, procedure, and recovery) are compared in Fig. 1. The time of a care episode (i.e. time elapsed between registration and discharge) ranged from 108 to 455 min. All 120 patients successfully underwent port removal. There were no complications related to surgery. Median time for the care episode was 235 min at the Main OR, 228 min at the Satellite OR, and 161 min at the Clinic (P b 0.001). Significant differences between the three sites were related to the time spent in specific phases of care within the hospital (Supplementary Table 1).
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx Table 1 Baseline characteristics.a, b
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Table 2 Comparison of total cost of care ratio, using Main OR as a referent. Regula Site of care
Characteristic
Main OR (N = 40)
Satellite OR (N = 40)
Clinic (N = 40)
P
Age (years) Sex Female Male ASA status I II III IV+ Race/ethnicity Non-Hispanic white Non-Hispanic black Hispanic Asian–American Primary diagnosis Carcinoma Sarcoma Myeloma Leukemia Lymphoma Other chronic condition Transplant rejection Other chronic conditions Lung or airway condition Mechanical cardiac condition Bleeding disorder Obesity
10.6 ± 5.8
8.9 ± 5.0
8.8 ± 4.9
0.252 0.571
17 (42.5) 23 (57.5)
17 (42.5) 23 (57.5)
13 (32.5) 27 (67.5) 0.069
0 (0.0) 25 (62.5) 15 (37.5) 0 (0.0)
1 (2.5) 29 (72.5) 10 (25.0) 0 (0.0)
0 (0.0) 35 (87.5) 5 (12.5) 0 (0.0)
25 (73.5) 2 (5.9) 4 (11.8) 3 (8.8)
27 (71.1) 3 (7.9) 5 (13.2) 3 (7.9)
24 (64.9) 3 (81.1) 6 (16.2) 4 (10.8)
4 (10.0) 17 (42.5) 17 (42.5) 7 (17.5) 5 (12.5) 5 (12.5) 2 (5.0)
0 (0.0) 3 (7.5) 20 (50.0) 8 (20.0) 5 (12.5) 4 (10.0) 0 (0.0)
0 (0.0) 2 (5.0) 13 (32.5) 17 (42.5) 7 (17.5) 1 (2.5) 0 (0.0)
3 (7.5) 5 (12.5) 0 (0.0) 3 (7.5)
2 (5.0) 0 (0.0) 1 (2.5) 0 (0.0)
3 (7.5) 1 (2.5) 2 (5.0) 2 (5.0)
0.992
Institution
Median
Range
95% confidence interval
Pa
Clinic Satellite OR Main OR
0.75 0.94 1.00
0.64–0.91 0.84–1.11 –
0.66–0.84 0.89–1.00 –
b0.001 0.187 Ref.
OR, operating room; Ref., referent.
between Main OR (64 min) and Satellite OR (61 min, P = 0.46). However, median surgeon time was significantly decreased at the Clinic procedure room (46 min) compared to the Main OR (64 min, P b 0.01). The time differences translated into significant cost differences across the three institutions (Table 2). As displayed in Fig. 2, overall cost was significantly decreased by 25% at the Clinic and by 6% at the Satellite OR (vs. referent Main, P b 0.01). A review of the time period before and after the initiation of the study revealed that the OR utilization remained unchanged and substantially more than 80%.
0.114
3. Discussion
0.875 0.025 0.259 0.232
ASA, American Society of Anesthesiologists physical status classification system. a Table values are mean ± standard deviation for continuous variables and number (column %) for categorical variables. b Numbers may not sum to total because of missing data, and percentages may not sum to 100% because of rounding.
Specifically, patients receiving care in the Main OR spent more time in the procedure room (56 min, 95% confidence interval [CI] 53–59 min), which represented the highest-cost space utilized in the process compared to counterpart patients at the Satellite OR (42 min, 95% CI 39–45 min, P b 0.001) and the Clinic (41 min, 95% CI 37–45 min, P b 0.001). Patients at the Clinic spent significantly less time in the pre-operative exam space compared to counterpart patients at Satellite OR (20 min vs. 69 min, P b 0.001) and Main OR (20 min vs. 74 min, P b 0.001). The intraprocedure duration ranged from 12 to 58 min, with median (95% confidence interval [CI]) times of 33 (31–35) min, 28 (26–30) min, and 30 (28–30) min for the Main OR, Satellite OR, and Clinic respectively (P = 0.16). Median surgeon time did not significantly differ
Fig. 1. Median time spent in each phase of the surgical process at each of the three sites (Main OR; Satellite OR; Clinic). OR, operating room.
The Institute of Medicine calls for a model of care that is high quality and marked by outcomes that are effective, equitable, and timely [8]. This model promotes value, defined as patient outcomes achieved per dollar expended. The importance of maximizing value is even more germane in the current era of health care cost containment. The Affordable Care Act's increasingly universal health insurance coverage has placed a commensurate responsibility on hospitals and health care systems to provide more cost-efficient quality care through value-based incentives. We postulated that performing low risk, routine procedures (that do not require a sterile room environment, rapid air turnover, or OR personnel) in a non-OR setting would further this goal. In this study of pediatric patients undergoing port removal, we found that the procedure was more cost-effective in the Clinic setting compared to the Main OR. The significant decrease in procedure time translated to a significant 25% decrease in cost. There were no significant differences in patient outcomes. Several existing publications address the topic of improving costeffectiveness of procedures. A pilot study conducted in 2005 by Catalano and colleagues investigated differences in time and charges to patients related to bone-anchored hearing aid placement among 19 adults [9].
Fig. 2. Distribution of cost among three sites of care (Main OR; Satellite OR; Clinic). The boxwhisker plot separates cost into quartiles, with the bottom line representing the 25th percentile, the middle line representing the 50th percentile and the upper line representing the 75th percentile. The bottom “whisker” represents the 5th percentile and the upper “whisker” represents the 95th percentile. OR, operating room.
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
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T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
The authors compared a traditional OR setting with an operative clinic, revealing a 50% decrease in physician time and 31% decrease in charges to patients in the clinic setting [9]. In the present study, we noted a decrease in time of care episode for port removal in the Clinic, compared with the Main OR. We believe that the underpinnings of this difference relate to a more efficient clinic model. Specifically, in the Clinic procedure room, pre-procedure patient interactions were integrated and, thus, pre-procedure discussion and peri-procedure handoffs were made more efficient. Similarly, French and colleagues used the TDABC methodology to prospectively institute process improvements in an adult pre-operative assessment center at MD Anderson Cancer Center, resulting in a 46% cost reduction in costs [10]. Most comparable to the present study, in 2007, Leblanc and colleagues performed a cost efficiency analysis of carpal tunnel surgery in an OR versus an ambulatory care setting using activity-based costing methodology. The authors noted that cost of care in the OR was four times more expensive than care provided in the ambulatory care setting [11]. A key distinction between the processes in this work by Leblanc and colleagues compared to the present study is that of an adult population and lack of anesthesia oversight. Specifically, in the setting of the carpal tunnel surgery, 73% of procedures were completed by surgeons without oversight by an anesthesia team [11]. On the other hand, in our study, anesthesia provision was consistent across clinic and OR settings, making cost comparisons more attributable to difference in location than difference in team composition. Specifically, the type of anesthesia administered did not systematically differ between sites. All sites, including the Clinic, were approved settings for general anesthesia. The anesthesiologist involved in each respective procedure was not restricted to a particular anesthetic method. While anesthetic choice may vary on a patient-to-patient basis, the anesthesia typically employed for port removal is intravenous induction followed by inhaled general anesthesia via laryngeal mask airway. In order to avoid comparing hospital charges or cost with their inherent biases, we leveraged TDABC methodology. TDABC allows for examination of procedures in different but clinically comparable settings. This method, with the construction of process maps, provides a detailed view of procedure times and allows for disaggregation of the episode of surgical care [7]. Using the granular approach of TDABC to costing procedures, the present study documented significant differences in time and cost of routine port removals at the Satellite OR and Clinic as compared to the Main OR. One important benefit of this study design is that processes and their corresponding times and costs can be compared across the same time period. Thus, independent of billing charges and reimbursement schemes, TDABC is a tool that allows hospitals to hone in on the true costs of delivering care and thus informs process changes in a systematic way. Especially in the setting of proposed economic restructuring of the American health care system (e.g. bundled payment model), TDABC analysis becomes a compelling methodology as hospitals work to optimize cost-effectiveness independent of reimbursement. For example, finding a lower cost setting for port removal would become even more crucial in the setting of bundled payments. This analysis demonstrated that the most time intensive and costly site of care was the Main OR, followed by the Satellite OR and the Clinic. The discrete activities underlying the process maps of the Main OR and the Satellite OR were identical. The Clinic procedure pathway, however, had fewer activities within the process map. This ultimately corresponded to time and cost savings, despite more intense involvement of higher-paid care personnel within each of the activities. Procedure-specific cost savings do not necessarily imply overall cost savings. For example, cost-savings was driven by decreased use of OR time; if un-used, this decreased use of OR time would not result in any cost-savings. As such, it is important to assess whether or not the removal of the cases described in this paper resulted in underutilized fixed resources in our Main OR. The OR schedule at our institution is scheduled “as needed” for the removal of port's. As such, no block time was left unused. In addition, a review of the time period before and after the initiation of the
study revealed that the OR utilization remained substantially more than 80% and was not changed. The OR management at our institution concluded that removing these cases from the Main OR allowed cases that needed to be scheduled for the Main OR to be done so with less interference. This is critical because much of the cost of the OR is in the form of capital and fixed labor. Moving procedures to a secondary location without maintaining constant scheduling of the Main OR (i.e. filling the new void in use) would result in costly externalities, as revenue would not be generated during this idle time. It was not within the scope of this study to evaluate the implications of such surgical changes on staff payment at the home institution (e.g. effect on overtime payment). Rather, we compared the overall cost of care for port removal depending on the location of the procedure. Given that the same preoperative evaluation would occur regardless of scheduled (compared to “as needed”) case status, it is unlikely that pre-operative duration would change with type of scheduling. There were important limitations to this study. Given the retrospective nature of this analysis, we were unable to control for factors such as underlying patient disease. For example, a greater proportion of patients with sarcoma underwent procedures in the Main OR, while more patients with leukemia underwent procedures in Clinic. However, this difference in underlying disease is unlikely to have caused any meaningful differences in peri-procedural approach, given the uniformity of the port removal procedure. Additionally, because of the current structure of the three sites' accounting data, pre-operative costs were embedded within the fixed and variable operative costs. Therefore, we were unable to determine the granular contribution of pre-operative time to overall cost of care. However, because the Clinic was shown to be the most cost-efficient facility, the lack of granularity likely led to a more statistically conservative comparison between the sites (i.e. bias toward the null). Likewise, turnover of the procedure room was included in the operative cost variable, thus limiting the ability to differentiate the cost implications associated with different turnover times. In all settings, the operative environment for this minor procedure was “clean” (as opposed to “sterile”). Time intervals calculated for each phase of the procedure were derived from entries within the medical record. In the Clinic setting, time stamps were not available for the period of time transition from the waiting area to pre-operative area. To account for this, an estimate based on the median time observed prospectively was employed. The magnitude of possible bias introduced from this measure was mitigated by the short time contribution of this phase of care, typically less than ten minutes. Time of discharge was likewise not clear for all patients at all sites. Therefore, the surrogate measure of time of last vitals prior to discharge was used as the discharge time. When discharge time was recorded, there was no more than a sixminute lag time between this surrogate measure and time of discharge. Finally, the hospital accounting data used to make the cost evaluations depend on the use of algorithms that estimate the average overhead and support costs of the spaces that patients occupy as they move through different phases of their surgical care. Because a micro-costing approach (i.e. detailing the specific combinations of disposables used during each different procedure) was not taken, differences in the use of disposables or medications that are not billed for were not accounted for in our analysis. However, this is considered normal variation in care delivery and would not be expected to substantially differ between sites. In conclusion, port removal was most cost-effective in settings outside of the OR with no significant difference in measurable clinical outcomes across the sites. In order to improve the value of care, institutions and providers should consider shifting elective procedures that do not require OR resources (such as routine port removals) from ORs to less resource-intensive settings such as clinic procedure or treatment rooms that are appropriately configured for such care. Future study will assess the important domain of patient satisfaction with minor procedures performed in non-OR settings. Supplementary data to this article can be found online at http://dx. doi.org/10.1016/j.jpedsurg.2016.07.017.
Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017
T.F. Devji et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
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Please cite this article as: Devji TF, et al, Safety and cost-effectiveness of port removal outside of the operating room among pediatric patients, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.07.017