Part II: Laboratory Analysis, Pharmacotherapy, Disposition, and Documentation
Author: Ralph J. Riviello, MD, FACEP, Assistant Professor and Clinical Research Director, Department of Emergency Medicine, Jefferson Medical College, Philadelphia, PA; Medical Director, Sexual Assault Treatment Center, Thomas Jefferson University Hospital, Philadelphia, PA.
Peer Reviewers: Allison Harvey, MD, FACEP, FAAEM, Clinical Faculty, Palmetto Richland Memorial Hospital Residency Program, SANE Medical Director Palmetto Health, Columbia, SC.; Meta Carroll, MD, FAAP, FACEP, Pediatric Emergency Physician Northwest Acute Care Specialists, Portland, OR, and Vancouver, WA.
This issue is the second installment of a two-part series on evaluation and management of sexual assault in the emergency department (ED). Part I of the series covered initial ED care, physical exam, and evidence collection. This issue will cover laboratory analysis, pharmacotherapy, disposition, follow-up, documentation, and court testimony. — The Editor
Most rape kits require a blood sample from the victim for blood typing and DNA analysis. Rape kit protocol may require collection of blood in a purple top tube with EDTA powder. The tube is labeled with patient name, date and time of collection, and collector’s initials. The tube then is placed in an envelope, sealed, labeled, initialed, and included in the kit. Alternatively, use of a filter paper (provided in the kit) for application of a few drops of the victim’s blood may be employed.
Concern for possible exposure to sexually transmitted infections (STIs) should prompt provision of antibiotic prophylaxis in the ED and close follow-up care for testing. Traditional teaching has been to obtain blood samples for syphilis (RPR), hepatitis B, and HIV, and genital swabs for gonorrhea and Chlamydia during the initial ED evaluation. However, there remains some controversy regarding the use of screening tests for STIs after sexual assault. Some centers operate under a protocol of providing antibiotic prophylaxis without STI testing in the ED, and testing only on follow-up visits. Because the incubation period for common STIs may be several days, a positive STI test from the ED may document an exposure prior to the assault. Thus, many practitioners (particularly within SANE programs) omit routine screening, believing that positive ED test results may be used to vilify the victim in the courtroom. Urinalysis can be obtained for pregnancy testing and for toxicology analysis. Pregnancy testing is used to rule out a pre-existing pregnancy in women who will take estrogen-containing emergency contraception (EC). However, use of the product Plan B, which is a progestin-only form of EC, precludes the need for pregnancy testing.
Drug-facilitated rape, most commonly with gamma hydroxybutyrate (GHB) or flunitrazepam (Rohypnol), has received significant attention in the medical community, law enforcement, and lay public. The Drug Induced Rape Prevention and Punishment Act of 1996 is a federal statute that provides a penalty of up to 20 years in prison for the intent to commit a crime of violence against an individual by distribution of a controlled substance to him or her without his or her knowledge. Some states further amended that law to include Rohypnol, GHB, and ketamine.1 If a drug-facilitated rape is suspected, or if specimens for toxicologic analysis are requested by police, urine and blood samples should be obtained after the patient consents. Most hospital drug screens do not detect the presence of GHB and Rohypnol, and these specimens need to be sent to special forensic labs to specifically test for these substances. In general, collect as much urine as possible, and sufficient blood for three gray top (fluoride) tubes. These specimens are labeled and sealed and usually not placed in the rape kit. Protocol may require delivery to a separate crime lab or other toxicology lab.
Finally, for those victims of sexual assault who have sustained bodily injury, other testing may be required, as dictated by clinical judgment and trauma management protocols.
Pharmacotherapy for Sexual Assault
Most medications provided to sexual assault victims are provided as prophylaxis against tetanus, STI, and pregnancy.
Tetanus. Victims who sustain tetanus-prone injuries should be provided tetanus prophylaxis using the same guidelines as other patients.
Sexually Transmitted Infections. Major STIs of concern to the sexual assault victim are gonorrhea, syphilis, Chlamydia, and trichimoniasis because of their relative high incidence. The Centers for Disease Control and Prevention (CDC) reports that 6-12% of adult victims contract gonorrhea after sexual assault.2 In addition, 4-17% of victims acquire Chlamydia after assault.3 Other STIs (i.e., trichimoniasis, syphilis, hepatitis, and HIV) also can be be contracted following sexual assault.
The decision to obtain genital or other specimens for STI diagnosis should be made on an individual basis. Laws in all 50 states strictly limit the evidentiary use of a survivor’s prior sexual history, including evidence of previously acquired STIs, as part of an effort to undermine the credibility of the survivor’s testimony. Cultures for N. gonorrhea and C. trachomatis should be obtained from any site of penetration or attempted penetration. FDA-approved nucleic acid amplification tests are more sensitive than culture testing. A positive test result should be confirmed by a second test. Enzyme immunoassay (EIA), non-amplified probes, and direct fluorescent antibody tests are not acceptable alternatives for culture because of unacceptably high false-negative rates. Nucleic acid amplification tests are not approved for use in pediatric patients and are not approved for use in non-urethral or non-vaginal/cervical sites. The CDC recommendations for STI prophylaxis in victims are listed in Table 1.2 A common side effect of STI prophylaxis is nausea. An anti-emetic may be prescribed, or the patient may take some of the medications the next day.
Hepatitis B. Sexual transmission accounts for approximately 30-60% of the estimated 240,000 new hepatitis B virus infections in the United States.2 Fully vaccinated patients do not require further therapy. If not vaccinated, then hepatitis B vaccine should be administered. Hepatitis immune globulin (HBIG) is not indicated. If vaccination status is unclear, obtain hepatitis serology and, if not immune, proceed with vaccination. Hepatitis B vaccination initiated in the ED requires medical follow-up at one and six months for completions of the series.
HIV. To date, the CDC reports three documented cases of HIV infection from sexual assault.4-6 The average risk of HIV transmission per contact of unprotected receptive anal intercourse is approximately 1-5%. For unprotected insertive anal intercourse and receptive vaginal intercourse, the risk is approximately 0.1-1%. For unprotected insertive vaginal intercourse it is less than 0.1%. The risk of receptive oral transmission has not been quantified.8-12 These data also can be quantified in the following manner: The per-act risk for HIV acquisition is 50 per 10,000 exposures for receptive anal intercourse; 10 per 10,000 exposures for receptive penile-vaginal intercourse; and 1 per 10,000 exposures for receptive oral intercourse.13-16 Few studies have looked at HIV rates in assailants.4,17 The largest study, from Rhode Island, showed that 1% of males convicted of sexual assault were HIV-positive, compared to 3% of all prisoners, and 0.3% of males in the general population.17
Animal and human studies on post-exposure prophylaxis (PEP) have shown up to a 67% reduction in risk of HIV transmission in occupational exposures and perinatal transmission.4,18 In 1999, the CDC-sponsored registry began assessing the availability of nonoccupational PEP nationwide in the United States. Of the 424 exposed patients reported, 92% were sexual exposures. Twenty-nine percent reported knowing the source was HIV-infected. Follow-up data were available on only 38% of patients, almost all of whom received PEP. Of those, 75% completed the initial regimen, 9% had the regimen modified, and 14% stopped early primarily because of side effects. One seroconversion was reported.18 A national survey of emergency physicians and residents demonstrated that non-occupational PEP is recommended most frequently following sexual assault (35%), unintentional needlesticks (25%), and unprotected sex and shared injection drug use materials (less than 15%). Sixty-four percent felt it was feasible to provide PEP in the ED, although only 46% felt confident in prescribing appropriate drugs for PEP.19 Another study of emergency physicians found that two-thirds had provided PEP, mostly for needlesticks. Forty-eight percent provided it following sexual assault. A majority of physicians said that they would provide it for adults and children assaulted by someone who was HIV-positive, had high HIV risk, or if the assailant was unknown.20
With regard to sexual assault victims, a 1998-1999 chart review from San Francisco General Hospital found that 57% of those seen had documentation of being offered PEP; 32% accepted. Of this group, only 38% completed a one-week follow-up visit and received the remainder of the medication.21 A small program in Massachusetts reported on 83 sexual assault survivors, of which 34 were eligible and 15 began medications. Sixty-four percent completed their 28-day regimen.22 In Vancouver, PEP is available for survivors of sexual assault. Acceptance has been reported at 28%, with 41% completing a follow-up 2-5 days later. Only 11% of those starting PEP completed the full course.23 A study in Brazil examined the outcome of women treated within 72 hours after assault with a 28-day regimen of either two or three medications (depending on the presence of injury and location of the assault.) The study found that of the 180 women treated, none seroconverted, while 4 (2.7%) of the 145 untreated did seroconvert.4 This study was not a randomized, controlled trial and the small sample size did not allow for statistical significance. Acceptance of PEP in North American and European cohorts is relatively low, although one French group did report a very high degree of acceptance.18 In addition, completion of the medications and follow-up in both cohorts appear poor.18
The decision to provide HIV prophylaxis after sexual assault must take into account the likelihood of exposure to HIV, the interval between exposure and treatment with PEP, and the risks and benefits of treatment. Some states mandate offering and providing HIV PEP to all sexual assault survivors.
Indications for PEP include:
- repeated abuse;
- assault by multiple perpetrators;
- perpetrator known to be HIV-positive or to have HIV risk factors (i.e., IV drug abuse, crack cocaine use, or high-risk sexual practices);
- high HIV prevalence in the area;
- unprotected oral, vaginal, or anal penetration; and
- presence of mucosal lesions.
Other factors to consider include the presence of oral, vaginal, or anal trauma; the site of exposure to ejaculate; the viral load of the ejaculate (if known); the presence of STI or genital ulcer in assailant or survivor; likelihood of transmission from the assault; likelihood of patient compliance; and treatment availability (i.e., cost and medical expertise). Children may be at higher risk of HIV transmission due to their association with multiple assaults and greater risk for mucosal trauma.
The CDC guidelines for HIV testing include initial testing then repeat testing at 3 and 6 months. This testing regimen is recommended regardless of HIV PEP therapy. If HIV testing is not done at the time of the initial ED evaluation, the patient should be referred within 72 hours to his or her primary care physician or to voluntary testing and counseling centers to establish HIV status at the time of the assault.
Several two- and three-drug PEP regimens are available. Compelling animal data support the practice of a 28-day course of therapy regardless of the regimen used.18 The regimen should be started within 72 hours of the exposure. The CDC recommendations for PEP are presented in Table 1.
If HIV PEP is given, it is recommended that a starter pack be provided and that the patient follow up within one week for evaluation of side effects and toxicity. At that time, the remainder of the medications can be prescribed. Common side effects include nausea (57%), fatigue (38%), and laboratory abnormalities (8%).4 The patient needs to be informed of the toxic effects of the medications, the need for strict compliance with the regimen, the necessity for close follow-up, and the fact that the true efficacy of PEP is unknown. Baseline complete blood count, serum chemistries, and liver enzymes should be obtained and repeated during the course of treatment.
Pregnancy. The risk of pregnancy following sexual assault is approximately 5%.24 Emergency contraception (EC) is the use of hormone pills to prevent pregnancy. In general, EC reduces the risk of pregnancy by 75%.25 The regimen is a combination of ethinyl estradiol and levonorgesterol or levonorgesterol alone (Plan B emergency contraception works through multiple mechanisms that vary, based on the time of administration within the menstrual cycle.) It is felt that EC most likely blocks or delays ovulation. Other effects may include preventing fertilization, sperm incapacitation, and changes in lining of the uterus that prevent the implantation of a human embryo.26-28 Medical experts agree that EC is not a medical abortion.27 It has been shown the EC does not affect an already established pregnancy and is safe if it is used inadvertently in early pregnancy.27 EC can be taken up to five days after unprotected intercourse.29 Side effects of EC include nausea, vomiting, and irregular vaginal bleeding. Common EC regimens include Ovral (two pills in the ED and two in 12 hours), and Plan B (one pill in the ED and again in 12 hours, or both pills administered simultaneously). Plan B seems to be best tolerated by patients.30 Other regimens using oral contraceptives can be used. Women should be advised to follow up for pregnancy testing, especially if their menses has not returned within 2-4 weeks from when it was expected.
The American College of Emergency Physicians’ policy statement on the “Management of the Patient with the Complaint of Sexual Assault” states that a victim of sexual assault should be offered prophylaxis for pregnancy and that physicians and allied health practitioners who find this practice morally objectionable or who practice at hospitals that prohibit prophylaxis or contraception should offer to refer victims of sexual assault to another provider who can provide these services in a timely fashion.31 A soon-to-be-published study in the Annals of Emergency Medicine found that many women have been unable to obtain ED from hospital EDs no matter what their circumstances.32
The majority of sexual assault victims treated in the ED will be discharged home. Depending on protocols, following release from the ED, the victim may be taken to the police station for further interviews. Follow-up for patients is discussed below. For those patients with concomitant serious injury or severe psychological trauma, hospital admission may be warranted. A small percentage of victims may require operative intervention for an exam under anesthesia, intractable vaginal bleeding, injury repair, or foreign body removal. The exact incidence of genital injuries requiring operative repair is unknown but is thought to be relatively low. In the Slaughter et al study of 213 victims with genital injury, only one required surgical repair.33 Another in postmenopausal women found a generally higher incidence of serious genital injury, with 25% requiring surgical intervention.34 In patients with severe or intractable bleeding from a genital injury, the vagina can be packed with gauze rolls and immediate gynecologic consult obtained.
Upon discharge from the ED, sexual assault victims should be provided instructions for follow-up. This follow-up may occur in a designated sexual assault follow-up clinic or with the patient’s own primary care physician or gynecologist. Initial follow-up should occur approximately two weeks post-assault. At this visit, the victim should be evaluated for pregnancy, as necessary, and STIs. Repeat testing for STIs is not necessary if prophylaxis was provided, unless the patient has symptoms.2 Results of all tests should be reviewed with the patient at this time as well. In addition, an examination may be performed to assess healing from injury or trauma.
The CDC recommends follow-up serologic testing for syphilis and HIV at 6, 12, and 24 weeks post-assault if initial test results were negative and these infections are likely to be present in the assailant.4 If hepatitis B vaccine was given, repeat vaccination should be given at 1-2 months and again 4-6 months after the first dose. If HIV prophylaxis was given, the patient should be provided enough medication until the next visit. The victim should be re-assessed 3-7 days after the initial visit to assess tolerance of medications. HIV antibody testing should be repeated as outlined above. In addition, repeat complete blood count, chemistry panel, and liver enzymes should be checked during PEP treatment. Finally, the survivor should be encouraged to follow up at the local rape crisis center. The most significant sequelae after sexual assault are psychological, and these centers can screen for problems and provide care at little or no cost to patients.
Accurate history and physical exam documentation is essential. (See Table 2 for a review of the elements of the forensic physical exam in sexual assault, including evidence collection and documentation.) Most jurisdictions and centers have standardized reporting forms for the medical evaluation of victims. Records should be clear, organized, legible, and complete. The date and time of examination should be documented. All history should be recorded in the victim’s own words using quotation marks. The victim’s affect should be documented in a descriptive, not subjective, manner. Three methods of documenting injury are recommended, including text description, diagrammatic illustration, and photography/colposcopy. All diagrams should be labeled. The location, size, shape, and color of any injury must be documented. Use of a measuring standard, like a photomacrograph, allows exact measurement. To effectively communicate genital injury site, the hours of the face of a clock are used as a locator. This avoids confusing terms and locators. Any laboratory and radiology test results, if performed, should be documented. Finally, any medications provided should be recorded.
Photodocumentation of general body and genital injuries is important. Options for photographs include Polaroid, 35-mm camera, digital camera, and the colposcope. The method selected should be based on cost, ease of operation, and admissibility in court. Digital photography allows the image to be reviewed at the time of examination and avoids the need for film processing. Digital images can be stored to a memory card or CD and later printed or shown in the courtroom directly from the computer. One major criticism of digital photography is the possibility of altering photos after they are taken. Therefore, all images should be downloaded to a password-protected, read-only format on CD-ROM (CD-R). This provides an electronic chain of evidence.
The first photograph taken should be an overview or full body shot that identifies the victim. Next, an orientation or medium-range shot is taken of an area of interest. Finally, proceed with a close-up of the area of interest. All close-up photos should be taken with and without a photo scale. The scale should be parallel with and in the same plane as the injury. In addition, consider contacting local law enforcement for a forensic photographer who can photodocument injuries (with the patient’s consent), and maintain strict adherence to the chain of custody of these images.
The role of the clinician is not to determine if a sexual assault occurred but rather to document the events and exam findings, collect evidence, and provide medical treatment. Thus, any remarks that imply judgment or belief of the occurrence of the event should not be made in the chart.
Chain of Custody
Chain of custody refers to the procedure of handling and accounting for all specimens through each step of evidence processing. It starts with the initial collection of the evidence and continues all the way to the courtroom. Usually there is a standardized form or evidence collection label that documents the transfer of evidence from medical personnel to the police officer.
All evidence should be placed in separate envelopes, bags, or containers, then sealed and initialed. Evidence should be labeled with the victim’s name, the date, examiner’s name, and specimen source. The individual pieces of evidence then are packaged together, sealed, and initialed. It should be labeled in the same format. Rape kits provide all containers and materials needed as well as instructions to maintain the chain of custody.
The individual collecting the evidence should not let it out of his or her direct control unless it is turned over to the police officer or secured in an area accessible to only one responsible individual. The police officer taking the evidence should sign for it, and a receipt of the evidence should be left with the examiner. If the evidence is not taken by the police at the time of evaluation, it should be stored in a locked cabinet or refrigerator (refrigerator is preferred if biological specimens are included). The evidence can be picked up at a later time and that officer will sign for it. Maintaining the chain of custody will ensure the validity and admissibility of forensic evidence in court.
Once the patient is discharged from the ED, the clinician’s job is not over. The initial examiner may be asked to testify in court. The physician or nurse examiner in court can be asked to serve two roles. One, as a factual witness, involves providing direct knowledge of information surrounding the specific case by sharing the medical record. The other role, as an expert witness, involves providing the court with an interpretation of the information being discussed. Usually the prosecuting attorney will delineate the role required for the case and should prepare his witness accordingly. It is important to remember that as a factual witness, the emergency physician is not on the stand to state whether or not a rape occurred, but to report or interpret facts. Whether appearing in court as a factual or expert witness, all testimony in a criminal trial is subject to cross-examination by the defense attorney.
Pre-hospital Providers. Care of the sexual assault victim often begins with pre-hospital providers, who should be trained in providing safety, security, and support to these patients. Because severe trauma in rape victims is rare, the physical needs of survivors often are limited.35
Most victims should be brought to a healthcare facility with the capabilities of providing a thorough forensic evaluation of injuries and expert evidence collection.36,37 These facilities are often outlined in pre-hospital triage protocols, or the EMS provider may be directed by the police to specific EDs. Pre-hospital care providers should focus on helping the victim maintain a sense of control and safety. It often is best to listen while saying little and to provide physical support and safety.38 Victims should not be judged regardless of circumstance, appearance, lifestyle, race, gender, or socioeconomic status.
Efforts should be made to ensure the privacy and confidentiality of the victim’s communication. With permission, a few limited questions that enable a focused assessment for injuries can be asked. Information about the perpetrator and/or details of the attack never should be solicited or questioned.
Physical assessment should focus on complaints or injuries. First-aid to wounds should be limited to preserving life and limb, as DNA or trace evidence may be lost. Because the patient/victim is essentially a portion of the crime scene, all efforts should be made to preserve evidence. Any modifications made to clothing by EMS workers should be documented in the chart. Any clothing that was removed or cut during evaluation should be saved, documented, and turned over to the hospital or law enforcement while maintaining chain of custody. Transport should not be delayed, but if time allows, the victim should be encouraged to bring a change of clothing.
Males. The NVAWS found there were 92,748 male rapes in the timeframe of 1995-1996. According to this data, it is estimated that 1 in 33 males will be sexually assaulted.39 The lifetime prevalence of sexual assault in males attacking males is approximately 3.6%.40 Because the Department of Justice’s Uniform Crime Reports do not include the incidence of males being victimized, true prevalence will remain unknown.
Males can be sexually assaulted by other males or by females. The percentage of male rapes is most likely higher in metropolitan areas with significant gay communities.40 Male rape is also seen among prisoners and other institutionalized populations. Because of fear, embarrassment, and stigma, males are less likely to report the rape to the police. However, a recent Department of Justice study showed that the difference in reporting rates between males and females was not statistically significant.41 Male assaults include oral intercourse, rectal intercourse, or both. In a study of 27 male sexual assaults, researchers found that 10% of their total sexual assault population was male, and a high percentage of patients had documented physical and anogenital trauma.40 The male patients presented an average of 13.5 hours following the attack, and the majority were assaulted by an unknown stranger or someone known fewer than 24 hours. In that study, the majority of men received prophylactic antibiotics against Chlamydia and gonorrhea, yet only 5 received HIV counseling, and 2 received HIV post-exposure prophylaxis. Sixty-three percent of men talked to the police while in the ED. Other studies have found similar assault characteristics and injuries.42,43 One of these studies included a large percentage of incarcerated males.42
The history and physical exam should proceed in the same manner as with a female patient, obviously omitting gynecologic questions. The physical exam should focus on signs of trauma and should include a thorough assessment of the oral cavity, perineum, and rectum. Anoscopy and toluidine blue can be used to document anorectal injury. Male victims should be offered standard antibiotic prophylaxis against gonorrhea and Chlamydia as well as hepatitis B. Male victims also are at risk for developing hepatitis A if anal penetration occurred. However, prophylaxis is not recommended because the disease usually is self-limited. Based on the HIV status of the victim and assailant, as well as the type of sexual assault, HIV prophylaxis should be offered to most male sexual assault victims. Male victims should be offered the same follow-up as female victims and should be referred to rape crisis centers for counseling.
Elderly. The National Crime Victimization Survey (NCVS) (1997) estimates the incidence of rape in older adults at 10 per 100,000 per year, and estimates that those older than 50 years represent 3% of sexual assault victims.44 Several other studies have shown that older sexual assault victims make up 2.2-4% of victims.34,45,46 Part of the difficulty in understanding the true incidence of sexual abuse in elders is the underreporting by victims and the varying definitions in studies of this population.
Many older adult victims do not know their assailants. Assailants may be total strangers, care givers, or significant others. Victims often are reluctant to disclose the assault secondary to their dependence on the perpetrator. Ramsey-Klausmik has shown that older victims of sexual assault in institutional settings often display subtle changes in behavior.47,48 These include sleep disorders, irritability, mood swings, depression, aggressive/regressive behaviors, mistrust of others, disturbed peer interactions, and nightmares. These changes can mimic other medical problems. In older adult victims living outside an institutional setting, family members perpetrate the majority of abuse and violence. Evaluation, evidence collection, and treatment protocols remain the same for elderly victims as for other sexual assault victims. History taking may be difficult due to dementia and cognitive impairment. Debilitating physical conditions can make the examination and evidence collection difficult. It has been shown that elderly female victims sustain more injuries and that their injuries are more severe than those in premenopausal women.34 Ramin found that injury was more severe in elderly victims and that 25% required surgical intervention.34 The risk for greater injury is hypothesized as secondary to decreased estrogen levels and loss of tissue elasticity. These injuries also take longer to heal.
Vital to appropriate disposition of the elder patient in the ED is a safety plan to ensure that the victim of assault is not returned to an unsafe home or to the care of an assailant. Engage the assistance of hospital and local social services, as well as the patient’s primary physician, to assist with placement of the patient in a safe environment.
Sexual assault survivors often present to the ED and count on clinicians to provide them with prompt care for physical injuries; empathy for the psychological trauma of the assault; advocacy in the form of evidence collection, accurate documentation, and court testimony; medical therapy to prevent disease and pregnancy; and appropriate referrals for ongoing medical and psychological therapy. The optimal response to a rape victim is provided with a team in place—with members who are confident in the knowledge of established protocols and roles, but experienced in providing victim-centered care. (See Table 3 for a list of sexual assault resources for physicians.) Compassionate medical care and advocacy of the victim has markedly improved in the past 40 years, and will do so in the future with continued research and the dedicated service of ED professionals.
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