1 Patient satisfaction and wait times following outpatient manual vacuum aspiration compared 2 to electric vacuum aspiration in the operating room: a cross-sectional study 3 4 Laura E. Dodge, ScD, MPHa,b; Lisa G. Hofler, MD, MPH, MBAa,b; Michele R. Hacker, ScD, 5 MSPHa,b; Sadia Haider, MD, MPHa,b 6 7 aDepartment of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, 330 Brookline 8 Ave, KS 3, Boston, MA 02215, USA 9 bDepartment of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, 25 10 Shattuck St, Boston, MA 02115, USA 11 12 Contact information: 13 Laura E. Dodge: ledodge@bidmc.harvard.edu; 1 (617) 667-2254 14 Lisa Hofler: lhofler@salud.unm.edu; 1 (617) 667-2254 15 Michele R. Hacker: mhacker@bidmc.harvard.edu; 1 (617) 667-2933 16 Sadia Haider: shaider2@bsd.uchicago.edu; 1 (773) 834-4063 17 18 Corresponding author: 19 Laura E. Dodge, ScD, MPH 20 Beth Israel Deaconess Medical Center 21 Department of Obstetrics and Gynecology 22 330 Brookline Avenue, KS 3 23 Boston, MA 02215 24 25 Running title: Patient satisfaction with manual vacuum aspiration 26 27 Word count: 2,025 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 ABSTRACT 52 Background 53 Outpatient manual vacuum aspiration (MVA) is a safe and equally effective alternative to electric 54 vacuum aspiration (EVA) in the operating room. This project was conducted to determine whether 55 outpatient MVA expedites care while maintaining patient satisfaction. 56 Methods 57 A cross-sectional study of a convenience sample of patients undergoing surgical management of 58 spontaneous abortion, induced abortion, or retained products of conception with either outpatient 59 MVA under local anesthesia or EVA in the operating room was conducted. Of 138 women 60 completing surveys, 48 (34.8%) underwent outpatient MVA and 90 (65.2%) underwent EVA in the 61 operating room. Procedure length, time from decision to procedure, and patient satisfaction were 62 assessed through a self-administered questionnaire completed post-procedure. 63 Results 64 Most (77%) patients in the MVA group reported waiting fewer than 2 hours from the time of their 65 decision to the procedure, while most (74%) EVA patients reported waiting over 12 hours 66 (P<0.001); the MVA group reported higher satisfaction with time to procedure (P=0.02). The 67 median procedure length was significantly shorter in the EVA group (10 vs. 20 minutes, P<0.001). 68 There was no significant difference between groups in overall satisfaction with the procedure 69 (P=0.16). 70 Conclusion 71 Outpatient MVA under local anesthesia is a suitable alternative to operating room-based EVA for 72 management of spontaneous abortion, induced abortion, and retained products of conception. 73 Outpatient MVA is associated with shorter decision-to-procedure time and is highly acceptable to 74 patients. Integration of outpatient MVA into clinical settings can add time- and resource-saving 75 options for uterine evacuation while maintaining a positive patient experience. 76 Keywords: manual vacuum aspiration; electric vacuum aspiration; uterine evacuation; patient 77 acceptability 78 79 BACKGROUND 80 Among the 1.1 million abortions performed each year, 77% are surgical procedures [8]. Electric 81 vacuum aspiration (EVA) was the original surgical technique described in North America for 82 performing surgical abortions [9,10,16]. Interest in manual vacuum aspiration (MVA) has grown, 83 and its safety and efficacy for abortion care in the first trimester are well established [6, 17]. Use of 84 MVA in an outpatient setting has distinct advantages over EVA in terms of cost [2]. Thus, MVA is 85 now selectively used by half of outpatient abortion providers in the U.S. to provide access to 86 abortion care for many women who otherwise could not afford it [11]. Additionally, previous work 87 has demonstrated the acceptability of MVA among providers [3] and patients [1,3,4,17], with one 88 study showing that many women prefer the increased feeling of privacy afforded by treatment in the 89 office setting [2]. 90 91 While MVA can be used for any indication for uterine evacuation, its growing use may broaden 92 access to induced abortion services, an increasingly critical issue in the current climate of expanding 93 abortion restrictions [5] and a decreasing number of providers [8]. After a large hospital in Chicago 94 moved its abortion services to an outpatient setting, the mean wait time for services fell from 20 95 days to 10 days, and the mean gestational age decreased from 11.0 weeks to 10.4 weeks [12]. 96 Among this group, the introduction of MVA was associated with a 15% increase in the number of 97 procedures per session [12]. 98 99 Given these advantages, the aim of this project was to determine whether the introduction of 100 outpatient MVA at an academic medical centre could expedite patient care compared to the typical 101 practice of EVA in the operating room for the same indications while also maintaining patient 102 satisfaction. 103 104 METHODS 105 In 2009, the Department of Obstetrics and Gynecology at our institution introduced outpatient 106 MVA under local anaesthesia as an alternative to EVA with intravenous anaesthesia performed in 107 the operating room for the treatment of spontaneous abortion, induced abortion, incomplete 108 abortion, and retained products of conception. To assess the impact of this policy change, a 109 convenience sample of women who chose surgical management of spontaneous abortion, induced 110 abortion, incomplete abortion, and retained products of conception were surveyed after their 111 procedure. Not all outpatient offices offered MVA. Women underwent MVA or EVA based on the 112 location of their diagnosis. Women seen in the inpatient triage area and in outpatient offices that had 113 MVA available underwent MVA procedures. Women diagnosed in outpatient offices without MVA 114 available had EVA in the operating room. Our institution does not consider scheduled uterine 115 evacuations “urgent” or “emergent” procedures; therefore, patients must fast prior to anaesthesia, 116 and procedure timing often depends on operating theatre availability. Due to fasting requirements 117 and operating room theatre availability, patients undergoing EVA generally go home to wait and 118 then return for their procedure. 119 120 Women who underwent a scheduled uterine evacuation with a uterine size less than 12 weeks of 121 gestation, were hemodynamically stable, were at least 18 years of age, and could proficiently read 122 and write in English were eligible to participate. Prior to their procedure, eligible women were 123 asked if they would complete a short self-administered questionnaire following their procedure. 124 This questionnaire assessed demographic characteristics, the time from when they made their 125 decision for uterine evacuation to the time they underwent the procedure, and their satisfaction with 126 the procedure. Statements regarding specific aspects of the procedure (e.g., “the number of staff 127 involved in my care was appropriate,” “I had the procedure quickly after the diagnosis or decision”) 128 were scored on a five-point Likert scale, with ‘1’ being ‘strongly agree’ and ‘5’ being ‘strongly 129 disagree.’ 130 131 Procedure characteristics such as procedure length, estimated blood loss, and concurrent intrauterine 132 contraceptive device placement were obtained from the medical record. Procedure length was 133 defined as the time from speculum insertion to speculum removal. The Committee on Clinical 134 Investigations at Beth Israel Deaconess Medical Center determined this was a quality assurance 135 project and thus exempt from review. 136 137 Data are presented as medians with interquartile range and counts with proportion. Comparisons of 138 continuous variables were made using the Wilcoxon rank sum test, and comparisons of categorical 139 variables were made using Fisher’s exact test. A P value <0.05 was considered statistically 140 significant. All data were analyzed using SAS 9.3 (SAS Institute, Cary, NC) and all tests were two 141 sided. 142 143 RESULTS 144 One hundred thirty-eight women completed post-procedure surveys. Of these 138 women, 48 145 (34.8%) underwent outpatient MVA under local anaesthesia, and 90 (65.2%) underwent EVA in the 146 operating room with either intravenous sedation or general anaesthesia (Table I). There were no 147 differences between women who underwent MVA and those who underwent EVA with respect to 148 age, education, race/ethnicity, gravidity, or parity (all P≥0.29). However, women did differ with 149 regards to the specialty of the treating attending physician; women undergoing MVA were more 150 likely to be treated by a family planning specialist than a general obstetrician-gynaecologist 151 (P<0.001). 152 153 Procedure characteristics differed significantly between women undergoing MVA and those 154 undergoing EVA with regards to indication for uterine evacuation (Table II). Missed abortion was a 155 more common indication in the EVA group (52.2% vs. 14.6%), and induced abortion was a more 156 common indication in the MVA group (58.3% vs. 38.9%; P<0.001). 157 158 Most (76.6%) women in the MVA group reported waiting fewer than 2 hours from the time of their 159 treatment decision to the time of the procedure, while most (73.6%) EVA patients reported waiting 160 over 12 hours (P<0.001). Nearly all (94.4%) women undergoing EVA left the hospital or clinic 161 after making the decision to have surgery and returned later for their procedures, whereas only 162 27.7% of women undergoing MVA left the hospital or clinic prior to having their procedures 163 (P<0.001). Total procedure time was 10.0 (8.0 – 13.0) minutes among women undergoing EVA and 164 20.0 (15.0 – 25.0) minutes among women undergoing MVA (P<0.001); there was no difference in 165 procedure time between family planning specialists and general obstetrician-gynaecologists overall 166 (P=0.27) or in the MVA (P=0.78) or EVA (P=0.16) group. Notably, one third of women 167 undergoing MVA had intrauterine contraceptive devices placed during the procedure, which was 168 included in the overall procedure time, while no patients undergoing EVA underwent concurrent 169 intrauterine device insertion. 170 171 Overall, there was no difference in the proportion of women who reported being very satisfied with 172 the procedure in the EVA group (77.8%) and the MVA group (62.5%; P=0.06; Table III). EVA 173 patients did not have the option to have a support person present during their procedure, but nearly 174 all (95.7%) women undergoing MVA strongly agreed or agreed that they liked having this option 175 available. While there was no difference in patients’ preference for location (hospital-based 176 operating room or outpatient office; P=0.35), women undergoing MVA were significantly more 177 likely than those undergoing EVA to agree that the time to their procedure was reasonable (P=0.02). 178 179 DISCUSSION 180 This study demonstrates that outpatient MVA is associated with significantly shorter patient wait 181 times and increased patient satisfaction with their wait times. There was no difference between the 182 groups in the proportion of women who reported being highly satisfied with their procedure. 183 Although we found significantly shorter procedure durations for women undergoing EVA compared 184 to MVA, prior research has been mixed. Several studies have found no significant differences 185 between MVA and EVA procedure times in first and second trimester procedures [3], but a 186 systematic review showed that EVA may have shorter procedure times due to the need to empty the 187 MVA syringe during the procedure [17]. The differences in procedure times in our study may also 188 be due to concomitant intrauterine device placement for one third of MVA patients. EVA procedure 189 times did not include time in the preoperative area, receiving anaesthesia, and recovering from 190 anaesthesia, all of which take longer in the peri-operative setting than in the outpatient office. 191 192 As access to induced abortion becomes increasingly restricted throughout the country, it is 193 important to maximize access where possible. One way of maximizing access is by increasing the 194 number of procedures that can be performed in a single centre, as was shown with a 15% increase in 195 capacity when a large Chicago hospital moved their abortion procedures to an outpatient facility 196 [12]. Additionally, integration of MVA into the outpatient setting can allow other providers, e.g., 197 mid-level providers and family medicine physicians, to provide increased access to care for women 198 seeking induced abortion and also treat women who require surgical management of spontaneous or 199 incomplete abortion. 200 201 The use of MVA can also improve the patient experience by allowing shorter wait times prior to the 202 procedure. Women who choose surgical management of miscarriage or retained products of 203 conception likely want to have the procedure as soon as possible. By shortening the wait time, the 204 gestational age at the time of induced abortion also decreases as women can be treated sooner, and 205 larger decreases in wait time may be associated with fewer complications [13] and less patient 206 discomfort [14]. This may also impact women in states with gestational age restrictions on abortion, 207 as even a one-day delay can be the difference between being able to access a procedure and pay for 208 it versus the inability to safely access abortion care. This is especially important for women whose 209 care is delayed until the second trimester, as terminations in the second trimester are associated with 210 increased cost and complications and decreased access, as many states require all second-trimester 211 abortions to be performed in a hospital or ambulatory surgical centre [7,13]. Given the 10-day 212 difference in wait times shown in the study by Patel et al., increasing access to terminations in the 213 outpatient setting by multiple provider types could markedly improve timely access to abortion care 214 [12]. 215 216 Finally, MVA has the potential to save costs for the institution. A cost-effectiveness model 217 examining different care strategies for uterine evacuation in early pregnancies estimated that in the 218 U.S., MVA could save $779 million per year compared to EVA [15]. Moving uterine evacuation to 219 the office saved nearly $1,000 per case in the study by Dalton et al., while physician reimbursement 220 did not differ [2]. 221 222 CONCLUSION 223 This study demonstrates that outpatient MVA under local anaesthesia is a suitable alternative to 224 EVA in the operating room for management of spontaneous and induced abortion, as well as 225 retained products of conception. Outpatient MVA is associated with shorter time from diagnosis to 226 procedure and is acceptable to patients. Integration of outpatient MVA into clinical settings has the 227 ability to save resources while maintaining a positive patient experience and expediting patient care. 228 Further integration of outpatient MVA may be an important strategy to maintain access to induced 229 abortion services in the setting of increased abortion restrictions. Additionally, this would allow 230 women undergoing management of spontaneous abortion or incomplete abortion to access care in a 231 timely fashion within the comfort of their provider’s office. 232 233 LIST OF ABBREVIATIONS 234 EVA Electric Vacuum Aspiration 235 MVA Manual Vacuum Aspiration 236 237 DECLARATION OF INTEREST 238 Ethics approval and consent to participate 239 The institutional review board at Beth Israel Deaconess Medical Center determined this was a 240 quality assurance project. 241 Consent for publication 242 Not Applicable 243 Availability of data and materials 244 All data used and analyzed for this study will be available from the corresponding author upon 245 request 246 Competing interests 247 S.H. is an author for UpToDate. She is also the Title X Medical Director for the Illinois Department 248 of Public Health, which is a consultant position. The other authors declare that they have no 249 conflicts of interest. 250 Funding 251 Not applicable 252 Authors’ contribution 253 LED contributed to study design, analyzed and interpreted data, and wrote the manuscript. LGH 254 contributed to study design, collected and interpreted data, and critically edited the manuscript. 255 MRH contributed to study design, interpreted data, and critically edited the manuscript. SH oversaw 256 the research project, contributed to study design, interpreted data, and critically edited the 257 manuscript. 258 Acknowledgements 259 Not applicable 260 261 REFERENCES 262 263 1. Bird ST, Harvey SM, Beckman LJ, Nichols MD, Rogers K, Blumenthal PD. Similarities in 264 women's perceptions and acceptability of manual vacuum aspiration and electric vacuum 265 aspiration for first trimester abortion. Contraception. 2003; 67(3):207-212. 266 2. Dalton VK, Harris L, Weisman CS, Guire K, Castleman L, Lebovic, D. 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Patient characteristics Electric vacuum Manual vacuum Characteristic aspiration aspiration P n=90 n=48 Age (years) 33.4 (26.9 – 37.2) 32.3 (27.7 – 36.1) 0.98 Education 0.87 High school or less 11 (12.9) 7 (14.6) Some college 17 (20.0) 11 (22.9) College degree or more 57 (67.1) 30 (62.5) Race/ethnicity 0.29 Caucasian 44 (51.2) 24 (52.2) African American 17 (19.8) 15 (32.6) Asian 8 (9.3) 1 (2.2) Hispanic/Latina 9 (10.5) 4 (8.7) Other 8 (9.3) 2 (4.4) Gravidity 0.45 1 28 (31.3) 12 (25.0) 2 or more 62 (68.9) 36 (75.0) Parity 0.81 0 39 (43.8) 20 (41.7) 1 or more 50 (56.2) 28 (58.3) Vaginal parity 0.20 0 15 (32.6) 9 (32.1) 1 21 (45.7) 8 (28.6) 2 or more 10 (21.7) 11 (39.3) Attending of record <0.001 Family planning 35 (38.9) 35 (72.9) General Ob-Gyn 55 (61.1) 13 (27.1) 325 Ob-Gyn, obstetrician-gynaecologist 326 Data are shown as median (interquartile range) or n (%) 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 Table II. Procedure characteristics Electric vacuum Manual vacuum Characteristic aspiration (EVA) aspiration (MVA) P n=90 n=48 EBL 10.0 (0.0 – 50.0) 20.0 (20.0 – 25.0) 0.05 Length of the procedure 10.0 (8.0 – 13.0) 20.0 (15.0 – 25.0) <0.001 Time in the OR (EVA) or office (MVA) 32.5 (27.0 – 37.0) 130 (115 – 165) Concomitant IUD insertion 0 (0.0) 7 (33.3) 0.002 Sharp curettage used 24 (26.7) 1 (2.1) <0.001 Indication <0.001 Missed abortion 47 (52.2) 7 (14.6) Induced abortion 35 (38.9) 28 (58.3) rPOC after spontaneous abortion 4 (4.4) 9 (18.8) rPOC after induced abortion 1 (1.1) 3 (6.3) Other 3 (3.3) 1 (2.1) Patient wait times <0.001 <2 hours 13 (14.9) 36 (76.6) 2 – 6 hours 7 (8.1) 3 (6.4) 6 – 12 hours 3 (3.5) 1 (2.1) > 12 hours 64 (73.6) 7 (14.9) Patient left hospital/office after decision was made and returned for the procedure 84 (94.4) 13 (27.7) <0.001 344 Data are shown as median (interquartile range) or n (%) 345 IUD, intrauterine device; rPOC, retained products of conception 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 Table III. Patient satisfaction Electric vacuum Manual vacuum Characteristic aspiration aspiration P n=90 n=48 Agreed with the statements* Staff number was appropriate 1.0 (1.0 – 1.0) 1.0 (1.0 – 1.0) 0.51 Time to procedure was reasonable 2.0 (1.0 – 2.0) 1.0 (1.0 – 2.0) 0.02 Liked the location 1.0 (1.0 – 2.0) 1.0 (1.0 – 2.0) 0.35 Liked having a support person -- 1.0 (1.0 – 1.0) -- Perception of the procedure <0.001 Better than expected 63 (72.4) 16 (33.3) Worse than expected 0 (0.0) 9 (19.8) Same as expected 24 (27.6) 23 (47.9) Satisfaction Very satisfied 70 (77.8) 30 (62.5) 0.06 Satisfied 16 (17.8) 14 (29.2) 0.12 Neutral 4 (4.4) 4 (8.3) 0.45 371 Data are shown as median (interquartile range) or n (%) 372 *Statements were scored on the following five-point Likert scale: 1, strongly agree; 2, agree; 3, 373 neutral; 4, disagree; and 5, strongly disagree