J Community Health DOI 10.1007/s10900-015-0037-x
ORIGINAL PAPER
Differences in Treatment of Chlamydia trachomatis by Ambulatory Care Setting William S. Pearson1 • Thomas L. Gift1 • Jami S. Leichliter1 • Wiley D. Jenkins2
Ó Springer Science+Business Media New York (outside the USA) 2015
Abstract Chlamydia trachomatis (CT) is the most commonly reported sexually transmitted infection (STI) in the US and timely, correct treatment can reduce CT transmission and sequelae. Emergency departments (ED) are an important location for diagnosing STIs. This study compared recommended treatment of CT in EDs to treatment in physician offices. Five years of data (2006–2010) were analyzed from the National Ambulatory Medical Care Survey, and the National Hospital Ambulatory Medical Care Surveys (NHAMCS), including the Outpatient survey (NHAMCS-OPD) and Emergency Department survey (NHAMCS-ED). All visits with a CT diagnosis and those with a diagnosis of unspecified venereal disease were selected for analysis. Differences in receipt of recommended treatments were compared between visits to physician offices and emergency departments using Chi square tests and logistic regression models. During the 5 year period, approximately 3.2 million ambulatory care visits had diagnosed CT or an unspecified venereal disease. A greater proportion of visits to EDs received the recommended treatment for CT compared to visits to physician offices (66.1 vs. 44.9 %, p \ .01). When controlling for patients’ age, sex and race/ethnicity, those presenting to the ED with
Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. & William S. Pearson [email protected] 1
Division of STD Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA
2
Southern Illinois University School of Medicine, Springfield, IL, USA
CT were more likely to receive the recommended antibiotic treatment than patients presenting to a physician’s office (OR 2.16; 95 % CI 1.04–4.48). This effect was attenuated when further controlling for patients’ expected source of payment. These analyses demonstrate differences in the treatment of CT by ambulatory care setting as well as opportunities for increasing use of recommended treatments for diagnosed cases of this important STI. Keywords Presumptive treatment Chlamydia Sexually transmitted infection Sexually transmitted disease
Introduction Chlamydia trachomatis (CT) is the most commonly reported bacterial sexually transmitted infections (STI) in the US with nearly 1.5 million cases reported to the Centers for Disease Control and Prevention (CDC) in 2012 [1] and an estimated incidence of nearly 3 million new cases each year among people aged 25 years and older [2]. These infections carry a heavy economic burden on our society with an estimated direct healthcare cost of $500 million in 2008 (2010 dollars) [3]. Therefore, it is imperative to quickly diagnose and treat these infections in order to reduce costly transmission and sequelae. Previous work among people reporting having received treatment for CT found that nearly half received their care from a private physician office, likely due to the institution of routine screening of sexually active females in primary and gynecological care [4]. A recent study of reported cases of CT found that about one-third of reported cases identified private physicians’ offices or HMOs as the source, more than any other individual point of care [5]. However, emergency department (ED) utilization among young adults has increased
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substantially in the twentyfirst century, and EDs have been recognized as an important location for diagnosis and treatment of STIs [6]. Past work has shown that many people seek treatment for STIs in the emergency department setting [7, 8] and that people seeking care in the emergency department are at a greater risk of having STIs [9]. Furthermore, several studies have indicated that adherence to treatment guidelines for STIs are different depending on practice setting [10–12]. Historically, drug resistance has not been a problem with chlamydial infections when treated with the recommended course of antibiotics [13] and periodic presumptive treatment has even been recommended in certain situations as long as drug resistance is monitored [14]. In the US, the CDC recommends presumptive treatment in some circumstances before test results become available [13]. Reviews of the effectiveness of recommended treatment have shown that the use of either azithromycin or doxycycline for the treatment of uncomplicated chlamydia has been effective [15]. However, reports have suggested that treatment failures do exist in varied cohorts of patients. One such case study provided a picture of persistent infections of CT in patients based on likelihood of reinfection and showed that after controlling for sexual behavior before and after treatment, treatment failure still existed among a small group of study participants [16]. Another study showed decreased susceptibility to both azithromycin and doxycycline in isolates collected from recurrently infected female patients [17]. Furthermore, a recently conducted, double-blinded, randomized controlled trial showed approximately a 10 % treatment failure for chlamydial infection based on both clinical and microbiologic cure among men with non-gonococcal urethritis after a 3 week follow-up period [18]. Another study found doxycycline to be significantly more effective against CT than azithromycin in a small group of men [19]. This information suggests that chlamydial infections may not be treated adequately and that there is a need for further investigation into this issue. Therefore, due to potential treatment failure leading to re-infection and possible development of drug resistance, we analyzed data on how CT and unspecified venereal diseases are treated in different ambulatory care settings to elucidate treatment practice variations. This study used nationally representative data to provide information on the numbers of visits to both physician offices and EDs and compared recommended treatment of CT in EDs to treatment in physician offices.
Materials and Methods Five years of data (2006–2010) were analyzed from the National Ambulatory Medical Care Survey (NAMCS), and the National Hospital Ambulatory Medical Care Survey
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(NHAMCS), including both the Outpatient survey (NHAMCS-OPD) component and Emergency Department survey (NHAMCS-ED) component. Both the NAMCS and NHAMCS are national surveys, conducted annually by the National Center for Health Statistics (NCHS), and designed to collect information on the provision of services in ambulatory care settings. The NAMCS is focused on visits made to community-based physician offices and to community health centers. The NHAMCS has two components, the Outpatient survey that focuses on visits made to physician offices that are housed in hospital outpatient departments and the Emergency Department survey that focuses on visits made to emergency departments. Data from NAMCS and the NHAMCS-OPD were combined to provide a picture of visits to physician offices and the NHAMCS-ED was used to provide a picture of visits to emergency departments. Further information on survey design and data collection methods for these surveys can be found elsewhere [20]. Each visit had up to three International Classification of Disease, 9th Revision, (ICD-9) codes associated with the visit. For these analyses, visits that contained an ICD-9 code for CT in any one of the three possibly listed codes were selected as well as two additional codes (099.8 and 099.9) that identified unspecified and other specified venereal disease (Table 1). We included visits with an unspecified venereal disease diagnosis due to the potential for presumptive treatment of CT in light of a non-specific diagnosis. These visits were stratified by setting (i.e. primary care versus ED). Among these visits, age, sex and race of the patient was reported as well as whether a prescription for azithromycin or doxycycline was written or given at the time of the visit. Race was collected as a categorical variable including ‘‘white’’, ‘‘black’’ ‘‘Hispanic’’ or ‘‘other’’. Expected payment source for the visit was collected and was used as a proxy for insurance status. Patients with ‘‘Private Insurance’’, ‘‘Medicaid/CHIP’’ or ‘‘Medicare’’ were combined and labeled as insured while all others were considered uninsured. This dichotomy was made due to sample size limitations. Recommended treatment for CT was taken from CDC’s 2010 STD treatment guidelines [13]. The first line of recommended treatment could be azithromycin alone or doxycycline alone. An alternative treatment could include erythromycin or ofloxacin or levofloxacin (Table 2). Visits where doxycycline, erythromycin, ofloxacin or levofloxacin were given alone were too few to support weighted estimates. To account for this issue, any visit that contained a mention of any of the above mentioned drugs was considered to meet the recommended treatment guidelines. We first looked at the first line of recommended drug treatment (azithromycin or doxycycline) and then at any drug treatment including any of the recommended drugs.
J Community Health Table 1 List of ICD-9 CM codes for chlamydia
Table 2 Recommended regimens for treatment of Chlamydia
079.88
Other specified chlamydial infection
079.98
Unspecified chlamydial infection
099.41
Other nongonococcal urethritis, Chlamydia trachomatis
099.50 099.51
Other venereal diseases due to Chlamydia trachomatis, unspecified site Other venereal diseases due to Chlamydia trachomatis, pharynx
099.52
Other venereal diseases due to Chlamydia trachomatis, anus and rectum
099.53
Other venereal diseases due to Chlamydia trachomatis, lower genitourinary sites
099.54
Other venereal diseases due to Chlamydia trachomatis, other genitourinary sites
099.55
Other venereal diseases due to Chlamydia trachomatis, unspecified genitourinary site
099.56
Other venereal diseases due to Chlamydia trachomatis, peritoneum
099.59
Other venereal diseases due to Chlamydia trachomatis, other specified site
099.8
Other specified venereal diseases
099.9
Venereal disease, unspecified
First line treatment Azithromycin 1 g orally in a single dose OR Doxycycline 100 mg orally twice a day for 7 days Alternative regimens Erythromycin base 500 mg orally four times a day for 7 days OR Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR Levofloxacin 500 mg orally once daily for 7 days OR Ofloxacin 300 mg orally twice a day for 7 days Special considerations (pregnancy) Recommended regimens Azithromycin 1 g orally in a single dose OR Amoxicillin 500 mg orally three times a day for 7 days Alternative regimens Erythromycin base 500 mg orally four times a day for 7 days OR Erythromycin base 250 mg orally four times a day for 14 days OR Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR Erythromycin ethylsuccinate 400 mg orally four times a day for 14 days Source: CDC, sexually transmitted diseases treatment guidelines, 2010
Statistical Analyses National estimates were reported for all visits to physician offices and emergency departments regardless of diagnosis as well as for visits where CT was a diagnosis. These estimates were stratified by age, race, sex and insurance status of the patient.
Chi square tests were first used to test the bivariate relationship between recommended treatment and service location. Significance was assumed at the alpha \.05 level. These bivariate associations were further tested using multiple logistic regression analyses. Three models were constructed to test the association between receiving the recommended treatment for CT and service setting. The
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first was unadjusted where recommended treatment receipt was dependent upon setting (ED versus primary care [used as reference]). The second model adjusted the first for patient age, race and sex. The third model expanded the second to include the setting’s rural/urban status and expected payment source. All analyses were conducted with SUDAAN software (RTI International, Research Triangle Park, NC; available at http://www.rti.org/sudaan/) to take into account the complex sampling design of the surveys.
Results From 2006 to 2010, the weighted survey results indicated that there were nearly 6 billion ambulatory care visits made to physician offices and emergency departments, and just over 3 million of these visits contained a diagnosis code for CT or unspecified venereal disease. In our sample, we had an estimated 2.6 million visits to physician offices and an estimated 523,000 visits to EDs with one of the specified diagnoses. Among these visits, several differences were noted in the populations of patients receiving treatment for one of these diagnoses by location of service. The average age of patients was similar for both treatment settings. A greater proportion of patients visiting the ED were male and non-white, compared to those visiting a physician office. A greater proportion of visits made to physician offices were covered by insurance compared to visits made to the ED (Table 3). Overall, a significantly greater proportion of visits to EDs with a diagnosis of CT or unspecified venereal disease received a recommended treatment for CT compared to visits to physician offices. Among visits where azithromycin only was mentioned, there was no statistically significant difference in the estimated percentages of visits that received this treatment (51.5 ED vs. 37.6 % physician office, p = .13). Among visits where either azithromycin or doxycycline was mentioned, nearly two-thirds of the visits to EDs had this recommended treatment mentioned compared to less than half of the visits to physician offices (66.5 vs. 47.3 %) and this difference was statistically significant (p \ .05). Finally, among visits where any one of the recommended drugs was mentioned, nearly 70 % of visits to EDs had the recommended treatment mentioned compared to less than one half of visits to physician offices (68.3 vs. 47.9 %) and this difference was significant (p \ .05) (Table 4). In an unadjusted model, ED patients were found to be nearly two and a half times as likely to receive any recommended treatment for CT as visits made to physician offices (OR 2.24; 95 % CI 1.18–4.67; Table 5), and this difference remained after controlling for patient’s age, sex and race (OR 2.16; 95 % CI 1.04–4.48). However, further
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controlling for expected payment source eliminated the significance of the disparity in treatment (OR 1.80; 95 % CI 0.87–3.72; Table 5).
Discussion Management of CT infection is challenging, because asymptomatic infection is common and the results of diagnostic tests are not available at the time of the patient visit [13, 21]. When recall of patients for treatment is potentially problematic or when patients are at increased risk for CT infection, presumptive treatment is indicated [13]. These analyses demonstrate differences in the treatment of CT and unspecified STI by ambulatory care setting as well as opportunities for increasing rates of recommended treatment for diagnosed cases of important STIs. Overall, EDs appeared to be providing recommended treatment for CT as well as presumptive treatment for CT at greater rates than visits made to physician offices. These findings held true in a multivariable model that controlled for patient demographics, but lost significance when controlling for insurance coverage. However, this loss of significance could possibly be attributed to small sample size when stratifying by further independent variables, thus creating larger and less stable confidence intervals. Even so, these findings suggest that differences in treatment practices for STIs do occur based on treatment setting. A recent retrospective chart review of 1209 patients following the CDC STD treatment guidelines found that in the absence of a rapid clinic-based test for either CT or GC, clinical diagnosis and presumptive treatment were quite insensitive, with negative laboratory results later being reported for 70.9 % of patients treated for CT and 86.6 % of patients treated for GC [22]. A review of other studies of STI management in EDs found that presumptive treatment was both insensitive and non-specific, with both over- and under-treatment [23]. Further work in this area points to the use of simple algorithms based on the patient’s sexual history and age that would result in better detection of costly STIs [24, 25]. In our analyses, we did look for cases with a co-diagnosis of either non-gonococcal urethritis or cervicitis that may add to the symptomology of patients presenting for treatment. However, we found only six cases among our study population with these symptomatic diagnoses. It is possible that clinicians may be treating for STIs based on previous experience with patients as opposed to clinical results to treat STIs. These findings are similar to those found in a questionnaire examining presumptive treatment of CT and GC among ED providers at a tertiary care hospital in North Carolina where researchers found that providers relied heavily on physical and historical factors for presumptive treatment [26].
J Community Health Table 3 Ambulatory care visits, 2006–2010
Physician office
Emergency department
Unweighted number of visits
326,176
175,351
Weighted number of visits
5,396,707,794
625,670,520
Average age (years)
44.8
36.8
Female (%)
59.1
54.5
White (%)
82.8
72.7
Insured (%)
73.3
62.8
All ambulatory care visits
Ambulatory care visits with diagnosed Chlamydia Unweighted number of visits
257
168
Weighted number of visits
2,645,755
523,007
Average age (years)
25.6
25.4
Female (%)
68.5
59.5
White (%)
41.7
30.5
Insured (%)
78.5
49.4
Source: 2006–2010 National Ambulatory Care Survey, National Hospital Ambulatory Care Survey— Outpatient Department Visits and Emergency Department Visits
Table 4 Receipt of recommended treatment for Chlamydia by ambulatory care setting
Physician office
Emergency department
p*
994,423 37.6 %
269,083 51.5 %
.13
.03
First line Weighted number of visits receiving Azithromycin % of total Weighted number of visits receiving Azithromycin or Doxycycline
1,256,538
347,528
% of total
47.3 %
66.5 %
First or second line Weighted number of visits receiving Azithromycin or Doxycycline or Erythromycin or Levofloxacin or Ofloxacin or Amoxicillin
1,267,246
357,240
% of total
47.9 %
68.3 %
.02
Source: 2006–2010 National Ambulatory Care Survey, National Hospital Ambulatory Care Survey–Outpatient Department Visits and Emergency Department Visits * Chi square test
The data also suggest several complementary courses of action to consider. First is a more explicit acknowledgement of the role of EDs in STI intervention and control. The data presented here and in other studies consistently show the importance of EDs in identifying a large proportion of STI cases—as a percentage of total visits to each setting, CT was diagnosed in 70 % more visits to EDs than physician offices. EDs serve populations at increased risk (i.e. increased prevalence), and disproportionately serve specific populations at risk of STI who may not be reached through current intervention methods based upon routine female screening in various primary care venues (i.e. uninsured women and males). It is probable that most ED
patients with CT diagnoses in the data were symptomatic, but screening is important in CT control. Screening rates in sexually active women under the age of 25 are low in all settings, as shown by Healthcare Effectiveness and Data Information Set (HEDIS) reports [27]. Although the HEDIS measure for CT screening has been in use for over 10 years, screening rates of women who receive routine healthcare services are low. This does not address individuals who do not seek/receive regular primary care. This study shows that the ED setting fills some of the ‘gaps’ in comprehensive STI care at the national scale. Complementary to this finding is the continuing need for and utility of sensitive, specific, and cost-effective rapid
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J Community Health Table 5 Logistic regression model for differences in receipt of recommended treatment for Chlamydia b
OR
95 % CI
Physician office
0.00
1.00
1.00-1.00
Emergency department
0.85
2.24
1.18-4.67
Physician office
0.00
1.00
1.00-1.00
Emergency department
0.77
2.16
1.04-4.48
0.00
1.00
1.00-1.00
0.59
1.80
0.87-3.72
Model 1
Model 2
Model 3 Physician office Emergency department
Source: 2006–2010 National Ambulatory Care Survey, National Hospital Ambulatory Care Survey–Outpatient Department Visits and Emergency Department Visits Model 1: Unadjusted model Model 2: Controlling for age, sex and race of patient Model 3: Controlling for age, sex and race of patient, and expected payment source for visit (insured)
assays to provide on-site diagnosis of infection status. This is particularly important in the ED setting where a lack of follow up/return visits is common and a driving motivation for presumptive diagnoses [23]. In primary care, this would potentially eliminate the need for a return visit and increase the treatment rate, especially since azithromycin can be provided in the clinic and directly observed [13]. Unfortunately, a large proportion of presumptive diagnoses are incorrect, which can lead to emotional distress and concerns regarding appropriate treatment and antimicrobial susceptibility [28]. Finally, the data point to the need for consistent and constant training of healthcare professionals at multiple levels on the correct diagnosis, treatment, and follow up for patients with chlamydial infection. In the absence of clinicbased diagnostic tests, treatment that relies strictly on symptoms creates concerns regarding antimicrobial susceptibility/resistance and treatment failure. Clinicians should be aware of the proper procedures and caveats regarding different STI treatment options and the appropriate follow up needed. Finally, coordination between the ED and other community agencies can accommodate the longer-term aspects of STI patient follow up and care. This might include coordinating with the local health department for managing activities such as partner identification and notification, expedited partner therapy, and personal risk reduction counseling. Limitations The findings of this work should be interpreted with the understanding of its limitations. First, these analyses did
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not take into account why the patient presented for the visit. It is possible that the visit, especially in the physician’s office, was due to a follow up for a previously treated problem related to an STI. Further, the survey instrument only required the drug to be mentioned at the visit and not necessarily given or even prescribed at the time of the visit. Therefore, it is possible that a follow-up visit would mention a drug that was prescribed or given at an earlier related visit. Another limitation of these findings is that there can be only three possible diagnoses associated with a single visit, and it is possible that for a visit with multiple diagnoses that any STI diagnosis was not listed in the first three (misclassification bias). Additionally, the use of ‘‘other specified venereal diseases’’ and ‘‘venereal disease unspecified’’ may be more common in the ED, where clinicians may be more likely to presumptively treat, compared to a physician office. A fourth limitation of this study is the small number of diagnosed STIs found in the sample. Cross-sectional surveys that do not specifically focus on STIs have difficulty in collecting large sample sizes of the desired diagnoses, especially when the diagnosis is not chronic in nature and can be sporadic in both its incidence and symptomology. The small number of STI diagnoses limited our ability to fully explore further possible relationships in the data.
Conclusions Despite screening guidelines and national intervention efforts, chlamydia remains the most commonly reported sexually transmitted infection in the US. Therefore, a key point to be made with our findings is that a recommended treatment for CT, when assessed at the time of this visit, was not made for a large proportion of all visits and that this phenomenon may have significant variations by setting, gender and race. As the US healthcare system evolves and increased rates of personal insurance and generally more-coordinated methods of care prevail, the role of the ED in CT treatment may remain important for those lacking insurance and regular sources of care. Management of CT in the ED presents challenges that may be addressed through provider education and coordination with local agencies to enhance follow-up. Conflict of interest The authors declare no competing interests in the completion of this study.
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ORIGINAL PAPER
Differences in Treatment of Chlamydia trachomatis by Ambulatory Care Setting William S. Pearson1 • Thomas L. Gift1 • Jami S. Leichliter1 • Wiley D. Jenkins2
Ó Springer Science+Business Media New York (outside the USA) 2015
Abstract Chlamydia trachomatis (CT) is the most commonly reported sexually transmitted infection (STI) in the US and timely, correct treatment can reduce CT transmission and sequelae. Emergency departments (ED) are an important location for diagnosing STIs. This study compared recommended treatment of CT in EDs to treatment in physician offices. Five years of data (2006–2010) were analyzed from the National Ambulatory Medical Care Survey, and the National Hospital Ambulatory Medical Care Surveys (NHAMCS), including the Outpatient survey (NHAMCS-OPD) and Emergency Department survey (NHAMCS-ED). All visits with a CT diagnosis and those with a diagnosis of unspecified venereal disease were selected for analysis. Differences in receipt of recommended treatments were compared between visits to physician offices and emergency departments using Chi square tests and logistic regression models. During the 5 year period, approximately 3.2 million ambulatory care visits had diagnosed CT or an unspecified venereal disease. A greater proportion of visits to EDs received the recommended treatment for CT compared to visits to physician offices (66.1 vs. 44.9 %, p \ .01). When controlling for patients’ age, sex and race/ethnicity, those presenting to the ED with
Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. & William S. Pearson [email protected] 1
Division of STD Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA
2
Southern Illinois University School of Medicine, Springfield, IL, USA
CT were more likely to receive the recommended antibiotic treatment than patients presenting to a physician’s office (OR 2.16; 95 % CI 1.04–4.48). This effect was attenuated when further controlling for patients’ expected source of payment. These analyses demonstrate differences in the treatment of CT by ambulatory care setting as well as opportunities for increasing use of recommended treatments for diagnosed cases of this important STI. Keywords Presumptive treatment Chlamydia Sexually transmitted infection Sexually transmitted disease
Introduction Chlamydia trachomatis (CT) is the most commonly reported bacterial sexually transmitted infections (STI) in the US with nearly 1.5 million cases reported to the Centers for Disease Control and Prevention (CDC) in 2012 [1] and an estimated incidence of nearly 3 million new cases each year among people aged 25 years and older [2]. These infections carry a heavy economic burden on our society with an estimated direct healthcare cost of $500 million in 2008 (2010 dollars) [3]. Therefore, it is imperative to quickly diagnose and treat these infections in order to reduce costly transmission and sequelae. Previous work among people reporting having received treatment for CT found that nearly half received their care from a private physician office, likely due to the institution of routine screening of sexually active females in primary and gynecological care [4]. A recent study of reported cases of CT found that about one-third of reported cases identified private physicians’ offices or HMOs as the source, more than any other individual point of care [5]. However, emergency department (ED) utilization among young adults has increased
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substantially in the twentyfirst century, and EDs have been recognized as an important location for diagnosis and treatment of STIs [6]. Past work has shown that many people seek treatment for STIs in the emergency department setting [7, 8] and that people seeking care in the emergency department are at a greater risk of having STIs [9]. Furthermore, several studies have indicated that adherence to treatment guidelines for STIs are different depending on practice setting [10–12]. Historically, drug resistance has not been a problem with chlamydial infections when treated with the recommended course of antibiotics [13] and periodic presumptive treatment has even been recommended in certain situations as long as drug resistance is monitored [14]. In the US, the CDC recommends presumptive treatment in some circumstances before test results become available [13]. Reviews of the effectiveness of recommended treatment have shown that the use of either azithromycin or doxycycline for the treatment of uncomplicated chlamydia has been effective [15]. However, reports have suggested that treatment failures do exist in varied cohorts of patients. One such case study provided a picture of persistent infections of CT in patients based on likelihood of reinfection and showed that after controlling for sexual behavior before and after treatment, treatment failure still existed among a small group of study participants [16]. Another study showed decreased susceptibility to both azithromycin and doxycycline in isolates collected from recurrently infected female patients [17]. Furthermore, a recently conducted, double-blinded, randomized controlled trial showed approximately a 10 % treatment failure for chlamydial infection based on both clinical and microbiologic cure among men with non-gonococcal urethritis after a 3 week follow-up period [18]. Another study found doxycycline to be significantly more effective against CT than azithromycin in a small group of men [19]. This information suggests that chlamydial infections may not be treated adequately and that there is a need for further investigation into this issue. Therefore, due to potential treatment failure leading to re-infection and possible development of drug resistance, we analyzed data on how CT and unspecified venereal diseases are treated in different ambulatory care settings to elucidate treatment practice variations. This study used nationally representative data to provide information on the numbers of visits to both physician offices and EDs and compared recommended treatment of CT in EDs to treatment in physician offices.
Materials and Methods Five years of data (2006–2010) were analyzed from the National Ambulatory Medical Care Survey (NAMCS), and the National Hospital Ambulatory Medical Care Survey
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(NHAMCS), including both the Outpatient survey (NHAMCS-OPD) component and Emergency Department survey (NHAMCS-ED) component. Both the NAMCS and NHAMCS are national surveys, conducted annually by the National Center for Health Statistics (NCHS), and designed to collect information on the provision of services in ambulatory care settings. The NAMCS is focused on visits made to community-based physician offices and to community health centers. The NHAMCS has two components, the Outpatient survey that focuses on visits made to physician offices that are housed in hospital outpatient departments and the Emergency Department survey that focuses on visits made to emergency departments. Data from NAMCS and the NHAMCS-OPD were combined to provide a picture of visits to physician offices and the NHAMCS-ED was used to provide a picture of visits to emergency departments. Further information on survey design and data collection methods for these surveys can be found elsewhere [20]. Each visit had up to three International Classification of Disease, 9th Revision, (ICD-9) codes associated with the visit. For these analyses, visits that contained an ICD-9 code for CT in any one of the three possibly listed codes were selected as well as two additional codes (099.8 and 099.9) that identified unspecified and other specified venereal disease (Table 1). We included visits with an unspecified venereal disease diagnosis due to the potential for presumptive treatment of CT in light of a non-specific diagnosis. These visits were stratified by setting (i.e. primary care versus ED). Among these visits, age, sex and race of the patient was reported as well as whether a prescription for azithromycin or doxycycline was written or given at the time of the visit. Race was collected as a categorical variable including ‘‘white’’, ‘‘black’’ ‘‘Hispanic’’ or ‘‘other’’. Expected payment source for the visit was collected and was used as a proxy for insurance status. Patients with ‘‘Private Insurance’’, ‘‘Medicaid/CHIP’’ or ‘‘Medicare’’ were combined and labeled as insured while all others were considered uninsured. This dichotomy was made due to sample size limitations. Recommended treatment for CT was taken from CDC’s 2010 STD treatment guidelines [13]. The first line of recommended treatment could be azithromycin alone or doxycycline alone. An alternative treatment could include erythromycin or ofloxacin or levofloxacin (Table 2). Visits where doxycycline, erythromycin, ofloxacin or levofloxacin were given alone were too few to support weighted estimates. To account for this issue, any visit that contained a mention of any of the above mentioned drugs was considered to meet the recommended treatment guidelines. We first looked at the first line of recommended drug treatment (azithromycin or doxycycline) and then at any drug treatment including any of the recommended drugs.
J Community Health Table 1 List of ICD-9 CM codes for chlamydia
Table 2 Recommended regimens for treatment of Chlamydia
079.88
Other specified chlamydial infection
079.98
Unspecified chlamydial infection
099.41
Other nongonococcal urethritis, Chlamydia trachomatis
099.50 099.51
Other venereal diseases due to Chlamydia trachomatis, unspecified site Other venereal diseases due to Chlamydia trachomatis, pharynx
099.52
Other venereal diseases due to Chlamydia trachomatis, anus and rectum
099.53
Other venereal diseases due to Chlamydia trachomatis, lower genitourinary sites
099.54
Other venereal diseases due to Chlamydia trachomatis, other genitourinary sites
099.55
Other venereal diseases due to Chlamydia trachomatis, unspecified genitourinary site
099.56
Other venereal diseases due to Chlamydia trachomatis, peritoneum
099.59
Other venereal diseases due to Chlamydia trachomatis, other specified site
099.8
Other specified venereal diseases
099.9
Venereal disease, unspecified
First line treatment Azithromycin 1 g orally in a single dose OR Doxycycline 100 mg orally twice a day for 7 days Alternative regimens Erythromycin base 500 mg orally four times a day for 7 days OR Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR Levofloxacin 500 mg orally once daily for 7 days OR Ofloxacin 300 mg orally twice a day for 7 days Special considerations (pregnancy) Recommended regimens Azithromycin 1 g orally in a single dose OR Amoxicillin 500 mg orally three times a day for 7 days Alternative regimens Erythromycin base 500 mg orally four times a day for 7 days OR Erythromycin base 250 mg orally four times a day for 14 days OR Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR Erythromycin ethylsuccinate 400 mg orally four times a day for 14 days Source: CDC, sexually transmitted diseases treatment guidelines, 2010
Statistical Analyses National estimates were reported for all visits to physician offices and emergency departments regardless of diagnosis as well as for visits where CT was a diagnosis. These estimates were stratified by age, race, sex and insurance status of the patient.
Chi square tests were first used to test the bivariate relationship between recommended treatment and service location. Significance was assumed at the alpha \.05 level. These bivariate associations were further tested using multiple logistic regression analyses. Three models were constructed to test the association between receiving the recommended treatment for CT and service setting. The
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first was unadjusted where recommended treatment receipt was dependent upon setting (ED versus primary care [used as reference]). The second model adjusted the first for patient age, race and sex. The third model expanded the second to include the setting’s rural/urban status and expected payment source. All analyses were conducted with SUDAAN software (RTI International, Research Triangle Park, NC; available at http://www.rti.org/sudaan/) to take into account the complex sampling design of the surveys.
Results From 2006 to 2010, the weighted survey results indicated that there were nearly 6 billion ambulatory care visits made to physician offices and emergency departments, and just over 3 million of these visits contained a diagnosis code for CT or unspecified venereal disease. In our sample, we had an estimated 2.6 million visits to physician offices and an estimated 523,000 visits to EDs with one of the specified diagnoses. Among these visits, several differences were noted in the populations of patients receiving treatment for one of these diagnoses by location of service. The average age of patients was similar for both treatment settings. A greater proportion of patients visiting the ED were male and non-white, compared to those visiting a physician office. A greater proportion of visits made to physician offices were covered by insurance compared to visits made to the ED (Table 3). Overall, a significantly greater proportion of visits to EDs with a diagnosis of CT or unspecified venereal disease received a recommended treatment for CT compared to visits to physician offices. Among visits where azithromycin only was mentioned, there was no statistically significant difference in the estimated percentages of visits that received this treatment (51.5 ED vs. 37.6 % physician office, p = .13). Among visits where either azithromycin or doxycycline was mentioned, nearly two-thirds of the visits to EDs had this recommended treatment mentioned compared to less than half of the visits to physician offices (66.5 vs. 47.3 %) and this difference was statistically significant (p \ .05). Finally, among visits where any one of the recommended drugs was mentioned, nearly 70 % of visits to EDs had the recommended treatment mentioned compared to less than one half of visits to physician offices (68.3 vs. 47.9 %) and this difference was significant (p \ .05) (Table 4). In an unadjusted model, ED patients were found to be nearly two and a half times as likely to receive any recommended treatment for CT as visits made to physician offices (OR 2.24; 95 % CI 1.18–4.67; Table 5), and this difference remained after controlling for patient’s age, sex and race (OR 2.16; 95 % CI 1.04–4.48). However, further
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controlling for expected payment source eliminated the significance of the disparity in treatment (OR 1.80; 95 % CI 0.87–3.72; Table 5).
Discussion Management of CT infection is challenging, because asymptomatic infection is common and the results of diagnostic tests are not available at the time of the patient visit [13, 21]. When recall of patients for treatment is potentially problematic or when patients are at increased risk for CT infection, presumptive treatment is indicated [13]. These analyses demonstrate differences in the treatment of CT and unspecified STI by ambulatory care setting as well as opportunities for increasing rates of recommended treatment for diagnosed cases of important STIs. Overall, EDs appeared to be providing recommended treatment for CT as well as presumptive treatment for CT at greater rates than visits made to physician offices. These findings held true in a multivariable model that controlled for patient demographics, but lost significance when controlling for insurance coverage. However, this loss of significance could possibly be attributed to small sample size when stratifying by further independent variables, thus creating larger and less stable confidence intervals. Even so, these findings suggest that differences in treatment practices for STIs do occur based on treatment setting. A recent retrospective chart review of 1209 patients following the CDC STD treatment guidelines found that in the absence of a rapid clinic-based test for either CT or GC, clinical diagnosis and presumptive treatment were quite insensitive, with negative laboratory results later being reported for 70.9 % of patients treated for CT and 86.6 % of patients treated for GC [22]. A review of other studies of STI management in EDs found that presumptive treatment was both insensitive and non-specific, with both over- and under-treatment [23]. Further work in this area points to the use of simple algorithms based on the patient’s sexual history and age that would result in better detection of costly STIs [24, 25]. In our analyses, we did look for cases with a co-diagnosis of either non-gonococcal urethritis or cervicitis that may add to the symptomology of patients presenting for treatment. However, we found only six cases among our study population with these symptomatic diagnoses. It is possible that clinicians may be treating for STIs based on previous experience with patients as opposed to clinical results to treat STIs. These findings are similar to those found in a questionnaire examining presumptive treatment of CT and GC among ED providers at a tertiary care hospital in North Carolina where researchers found that providers relied heavily on physical and historical factors for presumptive treatment [26].
J Community Health Table 3 Ambulatory care visits, 2006–2010
Physician office
Emergency department
Unweighted number of visits
326,176
175,351
Weighted number of visits
5,396,707,794
625,670,520
Average age (years)
44.8
36.8
Female (%)
59.1
54.5
White (%)
82.8
72.7
Insured (%)
73.3
62.8
All ambulatory care visits
Ambulatory care visits with diagnosed Chlamydia Unweighted number of visits
257
168
Weighted number of visits
2,645,755
523,007
Average age (years)
25.6
25.4
Female (%)
68.5
59.5
White (%)
41.7
30.5
Insured (%)
78.5
49.4
Source: 2006–2010 National Ambulatory Care Survey, National Hospital Ambulatory Care Survey— Outpatient Department Visits and Emergency Department Visits
Table 4 Receipt of recommended treatment for Chlamydia by ambulatory care setting
Physician office
Emergency department
p*
994,423 37.6 %
269,083 51.5 %
.13
.03
First line Weighted number of visits receiving Azithromycin % of total Weighted number of visits receiving Azithromycin or Doxycycline
1,256,538
347,528
% of total
47.3 %
66.5 %
First or second line Weighted number of visits receiving Azithromycin or Doxycycline or Erythromycin or Levofloxacin or Ofloxacin or Amoxicillin
1,267,246
357,240
% of total
47.9 %
68.3 %
.02
Source: 2006–2010 National Ambulatory Care Survey, National Hospital Ambulatory Care Survey–Outpatient Department Visits and Emergency Department Visits * Chi square test
The data also suggest several complementary courses of action to consider. First is a more explicit acknowledgement of the role of EDs in STI intervention and control. The data presented here and in other studies consistently show the importance of EDs in identifying a large proportion of STI cases—as a percentage of total visits to each setting, CT was diagnosed in 70 % more visits to EDs than physician offices. EDs serve populations at increased risk (i.e. increased prevalence), and disproportionately serve specific populations at risk of STI who may not be reached through current intervention methods based upon routine female screening in various primary care venues (i.e. uninsured women and males). It is probable that most ED
patients with CT diagnoses in the data were symptomatic, but screening is important in CT control. Screening rates in sexually active women under the age of 25 are low in all settings, as shown by Healthcare Effectiveness and Data Information Set (HEDIS) reports [27]. Although the HEDIS measure for CT screening has been in use for over 10 years, screening rates of women who receive routine healthcare services are low. This does not address individuals who do not seek/receive regular primary care. This study shows that the ED setting fills some of the ‘gaps’ in comprehensive STI care at the national scale. Complementary to this finding is the continuing need for and utility of sensitive, specific, and cost-effective rapid
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J Community Health Table 5 Logistic regression model for differences in receipt of recommended treatment for Chlamydia b
OR
95 % CI
Physician office
0.00
1.00
1.00-1.00
Emergency department
0.85
2.24
1.18-4.67
Physician office
0.00
1.00
1.00-1.00
Emergency department
0.77
2.16
1.04-4.48
0.00
1.00
1.00-1.00
0.59
1.80
0.87-3.72
Model 1
Model 2
Model 3 Physician office Emergency department
Source: 2006–2010 National Ambulatory Care Survey, National Hospital Ambulatory Care Survey–Outpatient Department Visits and Emergency Department Visits Model 1: Unadjusted model Model 2: Controlling for age, sex and race of patient Model 3: Controlling for age, sex and race of patient, and expected payment source for visit (insured)
assays to provide on-site diagnosis of infection status. This is particularly important in the ED setting where a lack of follow up/return visits is common and a driving motivation for presumptive diagnoses [23]. In primary care, this would potentially eliminate the need for a return visit and increase the treatment rate, especially since azithromycin can be provided in the clinic and directly observed [13]. Unfortunately, a large proportion of presumptive diagnoses are incorrect, which can lead to emotional distress and concerns regarding appropriate treatment and antimicrobial susceptibility [28]. Finally, the data point to the need for consistent and constant training of healthcare professionals at multiple levels on the correct diagnosis, treatment, and follow up for patients with chlamydial infection. In the absence of clinicbased diagnostic tests, treatment that relies strictly on symptoms creates concerns regarding antimicrobial susceptibility/resistance and treatment failure. Clinicians should be aware of the proper procedures and caveats regarding different STI treatment options and the appropriate follow up needed. Finally, coordination between the ED and other community agencies can accommodate the longer-term aspects of STI patient follow up and care. This might include coordinating with the local health department for managing activities such as partner identification and notification, expedited partner therapy, and personal risk reduction counseling. Limitations The findings of this work should be interpreted with the understanding of its limitations. First, these analyses did
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not take into account why the patient presented for the visit. It is possible that the visit, especially in the physician’s office, was due to a follow up for a previously treated problem related to an STI. Further, the survey instrument only required the drug to be mentioned at the visit and not necessarily given or even prescribed at the time of the visit. Therefore, it is possible that a follow-up visit would mention a drug that was prescribed or given at an earlier related visit. Another limitation of these findings is that there can be only three possible diagnoses associated with a single visit, and it is possible that for a visit with multiple diagnoses that any STI diagnosis was not listed in the first three (misclassification bias). Additionally, the use of ‘‘other specified venereal diseases’’ and ‘‘venereal disease unspecified’’ may be more common in the ED, where clinicians may be more likely to presumptively treat, compared to a physician office. A fourth limitation of this study is the small number of diagnosed STIs found in the sample. Cross-sectional surveys that do not specifically focus on STIs have difficulty in collecting large sample sizes of the desired diagnoses, especially when the diagnosis is not chronic in nature and can be sporadic in both its incidence and symptomology. The small number of STI diagnoses limited our ability to fully explore further possible relationships in the data.
Conclusions Despite screening guidelines and national intervention efforts, chlamydia remains the most commonly reported sexually transmitted infection in the US. Therefore, a key point to be made with our findings is that a recommended treatment for CT, when assessed at the time of this visit, was not made for a large proportion of all visits and that this phenomenon may have significant variations by setting, gender and race. As the US healthcare system evolves and increased rates of personal insurance and generally more-coordinated methods of care prevail, the role of the ED in CT treatment may remain important for those lacking insurance and regular sources of care. Management of CT in the ED presents challenges that may be addressed through provider education and coordination with local agencies to enhance follow-up. Conflict of interest The authors declare no competing interests in the completion of this study.
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