Journal Pre-proof

Special Ambulatory Gynecologic Considerations in the Era of COVID-19 and

Implications for Future Practice

Megan A. Cohen, MD, MPH, Anna M. Powell, MD, MS, Jenell S. Coleman, MD, MPH,
Ms. Jean M. Keller, PAC, Ms. Alison Livingston, BSN, ACRN, Jean R. Anderson, MD

PII: S0002-9378(20)30621-9
DOI: https://doi.org/10.1016/j.ajog.2020.06.006
Reference: YMOB 13297

To appear in: American Journal of Obstetrics and Gynecology

Received Date: 8 May 2020

Revised Date: 27 May 2020
Accepted Date: 3 June 2020

Please cite this article as: Cohen MA, Powell AM, Coleman JS, Keller JM, Livingston A, Anderson
JR, Special Ambulatory Gynecologic Considerations in the Era of COVID-19 and Implications for
Future Practice, American Journal of Obstetrics and Gynecology (2020), doi: https://doi.org/10.1016/
j.ajog.2020.06.006.

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition
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© 2020 Elsevier Inc. All rights reserved.

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1 Special Ambulatory Gynecologic Considerations in the Era of COVID-19 and Implications

2 for Future Practice

3 Megan A. COHEN MD, MPHa,b,*, Anna M. POWELL, MD, MSa,b, Jenell S. COLEMAN MD,

4 MPHa,b, Ms. Jean M. KELLER, PACa,b, Ms. Alison LIVINGSTON, BSN, ACRNb, Jean R.

5 ANDERSON, MDa,b
a
6 Johns Hopkins University School of Medicine, Department of Gynecology and Obstetrics
b
7 Johns Hopkins HIV Women’s Health Program

9 Conflict of Interest: The authors report no conflict of interest.

10 No financial support was received for this work.

11 *Corresponding Author:

12 Megan A. Cohen, MD, MPH

13 Instructor, Gynecology & Obstetrics

14 Department of Gynecology & Obstetrics

15 Johns Hopkins University School of Medicine

16 600 N. Wolfe Street

17 Phipps 248B

18 Baltimore, MD 21287

19 Phone: 410-614-9178

20 Fax: 410-955-1003

21 Email: mcohen82@jhu.edu

22 Word count: Abstract – 349; Main text – 3,000

23
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24 CONDENSATION AND SHORT VERSION OF TITLE

25 Modifications to ambulatory gynecologic services should be made to expand and ensure

26 continued access to comprehensive reproductive healthcare during the COVID-19 pandemic and

27 beyond.

28

29 Short title: Ambulatory Gynecologic Considerations in the COVID-19 Era

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30 ABSTRACT

31 The COVID-19 pandemic has altered medical practice in unprecedented ways. While much of

32 the emphasis in obstetrics and gynecology to date has been on the as yet uncertain impacts of

33 COVID-19 in pregnancy and on changes to surgical management, the pandemic has broad

34 implications for ambulatory gynecologic care as well. In this article we review important

35 ambulatory gynecologic topics including safety and metal health, reproductive life planning,

36 sexually transmitted infections, and routine screening for breast and cervical cancer. For each

37 topic, we review how care may be modified during the pandemic, provide recommendations

38 when possible for how to ensure continued access to comprehensive healthcare at this time, and

39 discuss ways that future practice may change. Social distancing requirements may place patients

40 at higher risk for intimate partner violence and mental health concerns; threaten continued access

41 to contraception and abortion services; impact prepregnancy planning; interrupt routine

42 screening for breast and cervical cancer; increase risk of sexually-transmitted infection

43 acquisition and decrease access to treatment; and exacerbate already underlying racial and

44 minority disparities in care and health outcomes. We advocate for increased use of telemedicine

45 services with increased screening for intimate partner violence and depression using validated

46 questionnaires. Appointments for long-acting contraceptive insertion can be prioritized. Easier

47 access to patient-controlled injectable contraception and pharmacist-provided hormonal

48 contraception can be facilitated. Reproductive healthcare access can be ensured through reducing

49 needs for ultrasound and laboratory testing for certain eligible patients desiring abortion and

50 conducting phone follow-up for medication abortions. Priority for in-person appointments should

51 be given to patients with sexually-transmitted infection symptoms, particularly if at risk for

52 complications, while also offering expedited partner therapy. While routine mammography
 4

53 screening and cervical cancer screening may be safely delayed, we discuss society guideline

54 recommendations for higher-risk populations. There may be an increasing role for patient-

55 collected human papilloma virus self-samples using new cervical cancer screening guidelines

56 that can be expanded in light of the pandemic situation. While the pandemic has strained our

57 healthcare system, it also affords ambulatory clinicians with opportunities to expand care to

58 vulnerable populations in ways that were previously underutilized to attempt to improve health

59 equity.

60

61 Key Words:

62 Abortion, cervical cancer screening, contraception, COVID-19, health equity, intimate partner

63 violence, reproductive healthcare access, telemedicine

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64 MAIN TEXT

65 Introduction:

66 The United States (US) leads the world in total number of COVID-19 cases and deaths due to

67 COVID-191. As the pandemic spreads, obstetric and gynecologic (OBGYN) clinical care, as in

68 other disciplines, has changed and evolved in unprecedented ways. In the short-term, elective

69 gynecologic surgeries and non-urgent clinic visits have been canceled; for obstetrical patients,

70 prenatal care delivery and fetal-testing algorithms were modified. Telemedicine visits have

71 replaced many in-person visits. Prior regulatory barriers, such as state licensing restrictions and

72 billing constraints, have been loosened or eliminated, while measures to ensure telemedicine

73 compliance with patient-privacy laws have been strengthened.

74

75 As states and ultimately the entire country begin to cautiously re-open for business, the impact of

76 the COVID-19 pandemic on how we provide sexual and reproductive health care will change. In

77 particular, telemedicine can offer the opportunity to provide greater access to high quality care

78 while reducing patient barriers to health service utilization such as transportation difficulties,

79 time off from work, and access for those in remote locations. Telemedicine, including telephone

80 visits, may be ideal for counseling but can also allow comprehensive history-taking, initial triage

81 of certain problems, discussion of patient-uploaded pictures to patient portals, and can facilitate

82 laboratory/radiology workup to streamline the clinical evaluation.

83

84 To date, in OBGYN most of the attention in the literature is placed on pregnancy and COVID-19

85 and on potential risks associated with surgery. Ambulatory gynecologic considerations have

86 largely focused on stratifying risk by patient complaints or known disease processes to determine
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87 who could be seen in person urgently, who can be assessed via telemedicine for less urgent

88 problems, and who may be safely delayed until the current crisis has passed. We would like to

89 highlight ambulatory gynecologic situations that have received too little attention to date but are

90 of critical importance in assessing and maintaining health in women.

91

92 It is also important to note that the COVID-19 pandemic has a significant chance of exacerbating

93 racial and ethnic disparities which are pervasive in OBGYN, with minorities already at higher

94 risk of worse health outcomes and decreased access to health care and services, as will be further

95 discussed below2. COVID-19 itself may disproportionately impact minority communities for a

96 variety of reasons3,4, and there have been well-documented crises within vulnerable populations

97 including on American Native reservations, in incarcerated populations, in African-American

98 communities, and in immigrant and refugee populations. These populations may additionally

99 face barriers in accessing telemedicine5. Thus, we will need to advocate for continued payment

100 parity for video visits, but also for sufficient reimbursement for telephone visits after the

101 pandemic abates. Though a full discussion of health disparities highlighted by this crisis is

102 outside the scope of this paper, we will address ways to modify care now and in the future, which

103 may mitigate some of these disparities and improve overall health equity (Box).

104

105 Safety/Mental Health:

106 Intimate Partner Violence (IPV): Nearly 40% of women in the United States are victims of

107 sexual violence in their lifetimes and 20% are victims of physical intimate partner violence6.

108 Vulnerable populations including young adults, people who identify as sexual and gender

109 minorities, people with disabilities, and people of certain minority groups such as American
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110 Native and non-Hispanic black women are at high risk for experiencing IPV2. Recent reports

111 indicate that social-distancing measures may increase risk of IPV, by limiting the ability of

112 victims of violence to distance themselves from abusers or to access external support7. A history

113 of or ongoing IPV has a significant impact on a woman's physical and mental health8, including

114 increased risk for unintended pregnancy, poor obstetric outcomes, sexually transmitted infections

115 (STIs) including human immunodeficiency virus (HIV), and risk of death from homicide or

116 suicide6,9.

117

118 While important to assess at any time, during this time of increased psychological stress and

119 enforced social isolation it is particularly critical that safety be assessed at each clinical

120 encounter, in-person or virtual. There are a number of simple validated screens10 that can be

121 administered in either setting. However, it is important to be aware that with telemedicine,

122 patients may be unable to speak privately; a script to standardize language and alert patients that

123 these questions are being asked at all visits may be helpful. Providers should be alert to non-

124 verbal cues and provide contact information if further communication is desired11. Use of

125 private, patient-filled questionnaires through the electronic health record (EHR) patient portal

126 could be implemented with subsequent notification of providers if a patient screens positive. If a

127 patient can speak freely, we advocate for use of an evidence-based tool such as CUES

128 (Confidentiality, Universal Education and Empowerment, Support)12. CUES is a trauma-

129 informed intervention available to providers to facilitate discussions regarding unhealthy

130 relationships and potential consequences of relationship-based violence for various patient

131 populations including American Indian/Alaskan Native people; adolescents; lesbian, bisexual,
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132 gay, and trans/gender non-conforming individuals; and people living with HIV (PLHIV). A plan

133 for referral to further local resources should also be in place.

134

135 Depression and anxiety: Women are about twice as likely as are men to develop depression

136 during their lifetime13 and this risk may be pronounced at specific reproductive periods,

137 including adolescence, pregnancy, postpartum and during the menopausal transition14. The

138 psychological effects of isolation/quarantine, as well as fear of contagion for oneself or dealing

139 with illness and death in friends or family members may predispose to or exacerbate underlying

140 mental health problems, especially among patients with a history of trauma. A recent review of

141 the literature in the COVID-19 pandemic found that symptoms of anxiety and depression were

142 present in 16-28% of individuals15.

143

144 Universal screening for depression and anxiety in all adult patients in the primary care setting,

145 including pregnant and postpartum women, has been recommended by the US Preventive

146 Services Task Force (USPSTF)16 and the American College of Obstetricians and Gynecologists

147 (ACOG)17, while the Joint Commission recommends screening for suicidal ideation in patients in

148 all medical settings18. Several brief validated screening instruments for depression and anxiety

149 such as the Patient Health Questionnaire (PHQ) 2, the Ask Suicide-Screening Questions19,

150 Edinburgh Postnatal Depression Scale20, and the Edinburgh Postnatal Depression Scale-Anxiety

151 subscale21 can be effectively administered via telemedicine or patient portals with a plan for

152 referral for women who screen positive. OBGYNs can consider initiating pharmacotherapy for

153 appropriate patients to expedite treatment, but should refer certain patients to a psychiatrist,

154 including those with concern for bipolar disorder, significant anxiety, suicidal ideation, and
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155 concomitant substance abuse or eating disorder21. Patients who express active suicidal or

156 homicidal ideation, those with psychotic symptoms, and those with disorganized behavior or

157 thoughts need to be referred to the emergency department21. For women on psychotropic

158 medications, providers should ensure an adequate supply.

159

160 Reproductive Life Planning:

161 Prevention of unintended pregnancy: The most recent US data estimates that 45% of

162 pregnancies were unintended in 2011; although this represents a decrease of 6% from 2008, the

163 rate of unintended pregnancies in the US remains higher than in other industrialized countries.

164 Furthermore, certain subgroups, such as women who are poor, PLHIV and adolescents have

165 higher rates of unintended pregnancy22. While there are no data as yet to suggest that unintended

166 pregnancies will increase during the COVID-19 crisis, and prior studies of pandemic situations

167 have found that fertility may actually decrease23,24, patients may face challenges in accessing

168 contraceptive care, transport to pharmacies, supply chain issues, and may also experience

169 decreased ability to negotiate condom or contraceptive use25. Furthermore, contraceptive

170 counseling and ongoing attention to contraceptive needs may be neglected as other issues are

171 prioritized.

172

173 The International Federation of Gynecology and Obstetrics (FIGO) released a statement26

174 emphasizing that contraceptive and family planning services and supplies are core components

175 of essential health services and access to these services is a fundamental human right, including

176 during this pandemic. This commitment is echoed by other key global organizations27,28. In

177 action items, FIGO highlights the role of telemedicine in improving information and access to
 10

178 contraception and calls for expansion of postpartum family planning services, particularly long-

179 acting reversible contraception (LARC), including intrauterine devices (IUDs), implants and

180 injectables.

181

182 While clinics may seek to limit in-person care even for ancillary visits for depot

183 medroxyprogesterone acetate (DMPA) administration, caution should be given to simply

184 switching contraceptive methods without careful consideration and counseling, with attention to

185 individual patient needs related to safety, convenience, tolerability and adherence. Certain

186 subpopulations are likely to have greater prevalence of co-morbid conditions resulting in

187 contraindications to estrogen-containing contraceptives and/or concerns about drug-drug

188 interactions. DMPA may also be considered for subcutaneous self-injection, which has been

189 shown to be safe and acceptable to patients with even higher continuation rates than provider-

190 administered injections29,30. Patients who wish to initiate or discontinue LARCs should still be

191 able to come to clinic to do so, but providers may wish to triage common complaints and counsel

192 regarding potential extended use of LARC devices. Clinical trial data supports extended use of

193 LARC devices beyond approved durations: the copper T380A remains effective for 12 years31,

194 the 52mg levonorgestrel IUD for 7 years31,32, and the etonogestrel implant for 5 years of use32.

195 Providers could offer telemedicine visits to counsel patients on reproductive life planning using

196 shared decision-making including discussing extended use of LARC devices, instructing patients

197 on how to self-administer DMPA if desired, and consider advanced provision of emergency

198 contraception.

199
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200 Restrictions on clinic visits during pandemic conditions also affords an opportunity to reduce

201 barriers to obtaining and continuing hormonal contraception. For established patients, providers

202 should ensure adequate refills for prescription contraceptives are provided, ideally for one year.

203 For new patients without contraindications to estrogen-containing methods, inability to perform

204 an exam should not preclude prescribing combined hormonal contraception, particularly if a

205 recent normal blood pressure reading is on file or can be reported by the patient33. Where

206 available, patients may avail themselves of pharmacist-prescribed hormonal contraception34.

207 ACOG endorses a goal of ultimately achieving over-the-counter hormonal contraception33.

208

209 Access to abortion services: While several states are attempting to use the COVID-19 pandemic

210 to limit access to abortion35, ACOG and other societies have called for continued access to

211 abortion as essential reproductive healthcare services36. This should include ensuring continued

212 access to surgical termination of pregnancy despite restrictions on surgical procedures, as

213 abortion remains a time-sensitive procedure with significant risk of harm to a patient if

214 delayed37. Potential measures can be implemented to minimize contact with the healthcare

215 system and facilitate timely access to abortion services. ACOG endorses remote assessment of

216 gestational age without need for ultrasound verification for patients with a positive home urine

217 pregnancy test, regular menses, a sure last menstrual period, and no risk factors for ectopic

218 pregnancy38. Initial counseling and consents can be obtained via telemedicine, then signed on the

219 day of service. These measures could significantly improve access to services for patients in

220 states with restrictive laws, who have to travel for abortion services, or who face other barriers to

221 accessing care.

222
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223 Medication abortion protocols can also be updated to align with current pandemic restrictions.

224 Telemedicine-instructed administration of mifepristone where available has shown similar

225 outcomes compared to in-person clinician consultation39. Phone follow-up after medical abortion

226 combined with home pregnancy tests have also been shown to be safe, feasible, and associated

227 with similar loss to follow-up rates compared to in-person visits40–42. Clinicians may implement

228 or adapt aspects of a recently published “No-Test Medication Abortion” protocol that allows for

229 expansion of medication abortion up to 77 days gestational age43 given recent literature showing

230 safety and efficacy through that time period with repeated dosing of misoprostol44,45. In the

231 future, pending changes to regulatory approval and legislation, the entirety of medication

232 abortions may be conducted via telemedicine where appropriate given the safety, efficacy, and

233 patient satisfaction of direct-to-patient provision of mifepristone and misoprostol for at-home

234 use46.

235

236 Prepregnancy/Interconception Care: Prepregnancy and interconception care and counseling

237 are key strategies to identify, manage and treat risk factors present before pregnancy that can

238 harm fetal development and maternal health or increase risk of adverse pregnancy outcomes47.

239 While the SARS CoV-2 virus is likely to be with us for an indefinite period of time and

240 development of a safe and effective vaccine make take up to 1-2 years, life continues and many

241 women may wish to proceed with having a child. Pregnancy planning, desires and timing should

242 be addressed with all women of childbearing potential during the COVID-19 crisis, including the

243 unknown impact of pregnancy on the susceptibility or severity of COVID-19, and uncertain

244 maternal and fetal risks of COVID-19. Preconception discussions should be patient-centered and

245 involve a shared decision-making process, including the option of deferring conception until the
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246 peak of the pandemic is passed and/or more is known about the effect of this virus on pregnancy

247 or moving forward with conception. Telemedicine can help facilitate prepregnancy counseling

248 discussions to ensure chronic health conditions are optimized if a patient intends to pursue

249 conception.

250

251 Sexual Health:

252 Screening, Prevention, and Treatment of STIs: Since 2014 there has been a 19% increase in

253 cases of chlamydia, 63% increase in gonorrhea, 71% increase in primary and secondary syphilis

254 and 185% increase in congenital syphilis48. Undiagnosed and untreated STIs can lead to pelvic

255 inflammatory disease (PID), ectopic pregnancy, chronic pelvic pain, and adverse fetal and

256 neonatal outcomes. Heterosexual transmission of HIV accounted for 85% of US new infections

257 in 201849. Other psychosocial factors, including the use of alcohol or drugs inhibiting the ability

258 to negotiate safer sexual practices, diminished gender power, poverty, and partner violence

259 contribute to STI risk50,51. This may heighten patients’ risk for acquiring STIs under pandemic

260 conditions as discussed above. Priority for in-person visits should be given to women with

261 symptoms suggestive of an STI, especially if accompanied by pain raising concern for pelvic

262 inflammatory disease (PID)52. However, during the COVID-19 crisis the Centers for Disease

263 Control and Prevention “encourages development of innovative testing protocols for self-

264 collected clinical laboratory specimens”52. Syndromic management may be considered in

265 selected cases associated with genital ulcers or vaginal discharge without symptoms concerning

266 for PID52. Ideally, expanded regulatory approval for self-swabs can continue after the pandemic

267 to increase STI treatment for patients who are not able to access care or who may be reluctant to

268 undergo pelvic exams.

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269

270 Patients with confirmed STIs should be offered expedited partner therapy (EPT) when feasible,

271 which remains underutilized given implementation barriers53,54. Providers may advocate for

272 integration of EPT order sets into the EHR and education of local pharmacists in order to

273 facilitate increased EPT access55. Safer sexual practices, including the use of condoms, should be

274 discussed with patients who are at increased risk for STIs. The use of HIV pre-exposure

275 prophylaxis (PrEP) should be discussed with HIV-uninfected patients who are at increased risk

276 of HIV acquisition56. Telemedicine protocols57 and pharmacist-led PrEP programs58 have been

277 shown to be safe and effective among men who have sex with men, and should be considered for

278 expansion to the gynecologic at-risk population to increase PrEP access.

279

280 Cancer Screening:

281 Breast cancer: Patients at average risk of breast cancer can likely postpone routine breast

282 mammography until risks from the pandemic conditions are lowered, as suggested by expert

283 guidance59. Per these recommendations, women with prior Breast Imaging-Reporting and Data

284 System (BI-RADS) 3 mammograms who are due for follow up may also be postponed59. Outside

285 of emergent scenarios, priority for breast imaging should be given to women with BI-RADS 4 or

286 5 lesions requiring diagnostic imaging or breast biopsy. Screening in high-risk women including

287 women known to be BRCA carriers under 40 may be delayed, but this may be reconsidered if

288 delays are expected for greater than 6 months59. Telemedicine may be used to evaluate new

289 breast complaints, to determine need for in-person visit or referral for expedited imaging if

290 warranted, and to counsel patients on appropriate follow-up guidelines and alleviate potential

291 anxiety associated with delaying normal follow-up timelines.

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292 Cervical cancer: The American Society for Colposcopy and Cervical Pathology (ASCCP) has

293 endorsed guidance for management of cervical cancer screening tests in light of the COVID-19

294 pandemic and widespread suspension of elective procedures. These include postponing

295 colposcopy for patients with low-grade squamous intraepithelial lesions (SIL) for up to 6-12

296 months, potential postponement of diagnostic or excisional procedures for patients with

297 suspected or known high-grade SIL for up to 3 months, and attempted evaluation of those with

298 suspected invasive disease within 4 weeks of initial pathology results60. Providers should adapt

299 to local situations and use clinical judgment if they feel a patient is higher risk and needs to be

300 seen sooner.

301

302 Additionally, ASCCP recently released new risk-based guidelines to guide cervical cancer

303 screening, emphasizing human papilloma virus (HPV) testing for individuals over age 30 and the

304 role of primary HPV testing with or without reflex cytology61. The USPSTF also endorses

305 primary HPV-testing only strategies62. The pandemic may thus provide an opportunity to expand

306 use of patient-collected HPV self-swabs which have been shown to be acceptable to patients and

307 non-inferior to physician collection63–65, potentially leading to increased screening of under-

308 represented populations such as transgender or gender non-conforming patients66–68. For

309 immunocompromised patients requiring more urgent follow up but who are at high risk if they

310 acquire COVID-19, providers can consider integrating self-collection kits that are able to be

311 returned by mail into current practice.

312

313 Conclusion:
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314 We have discussed important considerations for ambulatory gynecologic care amidst the

315 COVID-19 pandemic. We call for increasing screening for IPV and depression utilizing the

316 patient portal; provide ways to ensure continued and expanded access to contraception and

317 abortion services; review recommendations for prepregnancy/interconception care; draw

318 attention to the importance of screening, prevention, and treatment of STIs; and continued

319 indicated screening for breast and cervical cancer.

320

321 The pandemic also affords us an opportunity to break down barriers and improve access to care

322 for all populations by expanding use of telemedicine including telephone visits to address the

323 digital divide; developing abortion protocols for eligible patients that reduce or remove costly

324 tests; encouraging movement toward patient-controlled, pharmacist-provided, or over-the-

325 counter access to contraceptives; advocating for decreased barriers to implementing expedited

326 partner therapy; and facilitating use of self-sample swabs for STI and HPV testing. Thus,

327 clinicians should “leverage intersectional, human rights centered frameworks,”25 ensure

328 continued access to comprehensive ambulatory gynecologic care, and strive to achieve health

329 equity for our patients now and in the future.

330
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331 ACKNOWLEDGEMENTS

332 The authors have no acknowledgements for this article.

333
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