Beruflich Dokumente
Kultur Dokumente
Abstract
Background: Prolonged turnaround time of Neisseria gonorrhoeae (NG) and
Chlamydia trachomatis (CT) test results may delay time to notification and treatment of
test-positive patients and result in unnecessary antimicrobial use in test negative
patients. This quasiexperimental study evaluated the impact of NG/CT rapid diagnostic
testing (RDT) in an urban emergency department (ED) on treatment appropriateness,
time to notification, and cost. Patients tested in December 2013January 2014
(traditional group, n = 200) were compared with those in December 2014January 2015
(RDT group, n = 200). There was a significant increase in treatment appropriateness in
the RDT group, 72.5% versus 60% (P = 0.008) and time to results notification was
significantly faster (median 17.4 versus 51.5 hours, P = 0.010). Availability of test
result prior to discharge was associated with increased treatment appropriateness (odds
ratio, 22.65 [95% confidence interval, 2.86179.68]). The RDT would save
approximately $37,000 annually. These results support the use of NG/CT RDT to
expand antimicrobial stewardship efforts within the ED.
Introduction
N. gonorrhoeae (NG) and C. trachomatis (CT) are the most common bacterial
sexually transmitted infections (STI) which can result in serious complications if left
untreated.(Centers for Disease Control and Prevention; Centers for Disease Control and
Prevention, 2015a) In 2014, there were more than 350,000 cases of NG and 1.4 million
cases of CT reported in the United States alone (Centers for Disease Control and
Prevention). Nonculture methods, including nucleic acid amplification tests (NAAT),
arewidely available for the detection of genital NG/CT and are the preferred diagnostic
tests recommended by the Centers for Disease Control and Prevention (CDC) (Centers
for Disease Control and Prevention, 2014). With traditional NAAT, many health care
facilities have a turnaround time between 1 and 4 days for results of NG/CT. This
prolonged time to results impacts time to patient and partner notification as well as
treatment for test-positive patients who do not receive empiric therapy. Meanwhile,
excessive empiric antimicrobial use in test-negative patients may contribute to
increasing rates of antimicrobial resistance (U.S. Department of Health and Human
Services Centers for Disease Control and Prevention, 2014).
The emergence of widespread antimicrobial resistance is a threat to public
health. The CDC considers drug-resistant NG as an immediate public health threat that
requires urgent and aggressive action (U.S. Department of Health and Human Services
Centers for Disease Control and Prevention, 2014). Since 1986, the CDC's Gonococcal
Isolate Surveillance Project has monitored NG susceptibility to different antimicrobial
therapies. Ceftriaxone and azithromycin, 2 of the last remaining antimicrobials with
reliable coverage against NG, now demonstrate elevated MICs (Centers for Disease
Control and Prevention National Center for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention).While the percentage of NG isolates with decreased susceptibility to
ceftriaxone peaked at 0.4% in 2011 and stabilized in 2013 at 0.05%, continued
surveillance is warranted (Centers for Disease Control and Prevention National Center
for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; Centers for Disease Control
and Prevention, 2015b). The CDC Sexually Transmitted Diseases treatment guidelines
recommend combination therapy for the treatment of NG to prevent the selective
pressure for resistance to the remaining treatment options (Centers for Disease Control
and Prevention, 2015b).
Antimicrobial stewardship programs have been developed within hospitals to
promote optimal prescribing of antimicrobial agents in an effort to increase efficacy,
improve patient safety, and reduce antimicrobial resistance (Dellit et al., 2007; Society
for Healthcare Epidemiology of America et al., 2012). The development of rapid
diagnostic tests (RDTs) can help to achieve these goals by providing timely detection of
infectious organisms and allowing for targeted antibiotic therapy. The Infectious
Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of
America (SHEA) advocate for the use of RDT to improve detection capabilities and to
guide appropriate treatment as part of an antimicrobial stewardship program. SHEA and
the IDSA also agree that investigations evaluating the development and cost-
effectiveness of RDT are a priority. A RDT NAAT for the detection of genital NG/CT
was approved in 2012. Independent analyses of the RDT have reported equivalent
sensitivity and specificity as compared with traditional NAAT (Gaydos et al., 2013;
Goldenberg et al., 2012; Tabrizi et al., 2013). A recently published open-label,
randomized, controlled trial in emergency department (ED) patients found that use of
the RDT for NG/CT resulted in decreased unnecessary antibiotic exposure in test-
negative patients (May et al., 2016). Subjects randomized to the RDT arm were required
to wait in the ED for 90 minutes following sample collection, increasing the likelihood
that the patient would be present at the time the test results became available (May et
al., 2016). This may not be feasible in a real-world setting. Additionally, the impact of
the RDT on time to patient notification of test results or time to appropriate treatment
was not evaluated.
The purpose of this studywas to determine if implementation of NG/CT RDT as
the standard of care in the ED would improve treatment appropriateness by decreasing
antimicrobial exposure in test-negative patients while increasing treatment rate in test-
positive patients. We hypothesized that the implementation of the RDT would result in
increased treatment appropriateness for NG/CT as well as improved time to patient
notification and decreased cost of care.
4. Selection of participants
A computer-generated report from the electronic medical record was
used to retrospectively identify all patients tested for NG/CT during the study
period. Data collected included patient characteristics, testing characteristics,
antimicrobial therapy administered, initial treatment appropriateness, time to test
results, time to patient notification of positive test results, time to appropriate
treatment, and ED length of stay.
The traditional testing group consisted of 200 consecutive patients
presenting to the ED between December 1, 2013 and January 31, 2014. Patients
tested for NG/CT were considered for empiric treatment prior to discharge at
provider discretion (Centers for Disease Control and Prevention, 2015b). Once
test results returned, ED staff notified patients who tested positive for NG/CT of
their results and provided counseling and education by telephone. Patients who
did not receive empiric treatment were provided with treatment either by a
telephone prescription or by request to return to the ED for parenteral
antimicrobial administration. If a patient was unable to be contacted after 3
telephone attempts, a certified letter wasmailed to the patient and patient
information was forwarded to the county health department for follow up.
The RDT was implemented for ED use in October 2014. The RDT group
consisted of 200 consecutive patients presenting to the ED between December 1,
2014 and January 31, 2015. If results were available prior to discharge, patients
with positive results were provided notification, counseling, and treatment for
NG/CT while in the ED. Test-negative patients were notified and spared
unnecessary antimicrobial administration. If patients were ready for discharge
prior to the completion of RDT results, providers had the option to provide
patients with empiric treatment and allow follow-up of results after discharge.
Providers were not encouraged to delay patient discharge in order to await RDT
results. ED staff would contact patients with positive results for notification,
counseling, and treatment following the same process as the traditional test. In
both groups, patients were also screened and treated for additional STIs (e.g.,
trichomonas) if indicated.
5. Outcomes
The primary end point of this study was to compare the percentage of
patients who received appropriate treatment during their index ED visit using the
traditional test versus the RDT for NG/CT. Appropriate treatment was defined
as the combined end point of test-positive patients receiving antimicrobial
therapy in concordance with the CDC 176 K.R. Rivard et al. / Diagnostic
Microbiology and Infectious Disease 87 (2017) 175-179 guidelines and test-
negative patients not receiving antimicrobial treatment.
Secondary end points included time to test results, time to patient
notification of positive test results, and time to appropriate treatment. Time to
test result was calculated as the time the laboratory received the sample to the
time that test results were uploaded to the medical record. Time to patient
notification of positive test results was calculated as the time the NG/CT results
became available to the time that patient notification was documented in the
medical record. Time to appropriate treatment for test-positive patients was
calculated as the time the NG/CT results became available to the time that
appropriate antimicrobial therapy was provided. Provision of appropriate
antimicrobial therapy included initial medication administration in the ED,
readmission to the ED for treatment, or a telephone prescription. A cost analysis
was performed using institutional financial data to determine the average cost of
appropriate and inappropriate treatment in both groups. Costs were derived
using the direct cost to the institution of the test, cost of the ED visit and revisit
based on diagnosis code, and cost of antimicrobials
.
6. Analysis
The studywas powered to detect a 15% absolute difference in appropriate
initial antimicrobial treatment using a 2-sided testwith =0.05 and = 0.2. A
15% effect size was chosen based on previous literature evaluating the
integration of RDTs into antimicrobial stewardship programs (Clerc et al., 2013;
Parta et al., 2010). It was determined that 167 patients in each arm would need
to be included in this study. Pilot data from the study site found that
approximately 125 patients per month were tested, therefore, 2 months were
included in each group with a maximum enrollment of 200 patients per group
(n=400).
For all baseline characteristics and study end points, categorical data
were compared using chi square or Fisher exact test; continuous data were
compared using Student's t test or theMannWhitney U test. Multivariate
logistic regression analysis was performed to determine clinically relevant
variables that were independently associated with treatment appropriateness. All
variables associated with appropriate therapy in bivariate analysis (P b 0.2) were
considered for inclusion in the multivariate model. Forward entry was used to
derive the final model for appropriate therapy. Significant variables in the final
model had a P b 0.05. Statistical testing was conducted using SPSS 21.0 (SPSS,
Chicago, IL)
Result
2. Main results
Initial treatment was considered appropriate in 60% of patients in the
traditional group compared with 72.5% in the RDT group (P = 0.008, Table 1).
This difference was driven by test-negative patients being spared unnecessary
antimicrobial therapy. For test-positive patients, empiric treatment was
appropriately administered at the index ED visit in 15 patients (78.9%) in the
traditional group and 18 patients (90%) in the RDT group (P=0.407). Median
time to test results was significantly decreased in the RDT group compared with
the traditional group (2.4 [1.412.0] versus 31.7 [9.7105.9] hours, P b 0.001),
as was time to patient notification of positive results (17.4 [0.093.0] versus
53.7 [26.979.9] hours, P = 0.010). Of note, there were 2 patients in the
traditional group (all treated empirically) and 7 in the RDT group (5 treated
empirically) who were unable to be notified of their positive test results via
telephone (P=0.092). There were no statistically significant differences in time
to test order or in ED length of stay (Table 1).
Discussion
Acknowledgements
The authors wish to acknowledge G. Robert DeYoung, PharmD, BCPS, for his
administrative and data management support as well as Cora Manby, Microbiology
Technical Specialist for her support with testing validation and implementation.
References
1. Centers for Disease Control and Prevention (CDC). Recommendations for the
laboratorybased detection of Chlamydia trachomatis and Neisseria
gonorrhoeae2014. MMWRRecomm Rep 2014;63(RR-02):119.
2. Centers for Disease Control and Prevention (CDC). Gonorrhea CDC fact sheet
(detailed version). Available at: http://www.cdc.gov/std/gonorrhea/stdfact-
gonorrhea-detailed.htm, 2015. [Accessed May 3, 2016].
3. Centers for Disease Control and Prevention (CDC). Sexually transmitted
diseases treatment guidelines, 2015. MMWR Recomm Rep 2015b;64(RR-03):1
137.
4. Centers for Disease Control and Prevention (CDC). Chlamydia CDC fact sheet
(detailed version). Available at: http://www.cdc.gov/std/chlamydia/stdfact-
chlamydia-detailed.htm. [Accessed May 3, 2016].
5. Centers for Disease Control and Prevention (CDC). Reported STDs in the
United States: 2014 National Data for Chlamydia, Gonorrhea, And Syphilis.
Available at: http://www.cdc.gov/std/stats14/std-trends-508.pdf. [Accessed May
3, 2016].
6. Centers for Disease Control and Prevention National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention. Sexually transmitted diseases
surveillance 2013. Available at: http://www.cdc.gov/std/stats13/surv2013-
print.pdf. [Accessed May 3, 2016].
7. Cepheid. Xpert CT/NG: package insert. Sunnyvale, CA: Cepheid; 2015. Clerc
O, Prod'hom G, Vogne C, et al. Impact of matrix-assisted laser desorption
ionization time-of-flight mass spectrometry on the clinical management of
patients with gramnegative bacteremia: a prospective observational study. Clin
Infect Dis 2013;56(8): 11017. http://dx.doi.org/10.1093/cid/cis1204.
8. Dellit TH, Owens RC, McGowan Jr JE, et al. Infectious Diseases Society of
America; Society for Healthcare Epidemiology of America. Infectious Diseases
Society of America and the Society for Healthcare Epidemiology of America
guidelines for developing an institutional program to enhance antimicrobial
stewardship. Clin Infect Dis 2007; 44(2):15977.
http://dx.doi.org/10.1086/510393.
9. Gaydos CA, Van Der Pol B, Jett-Goheen M, et al, CT/NG Study Group.
Performance of the Cepheid CT/NG Xpert rapid PCR test for detection of
chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol
2013;51(6):166672. http://dx.doi.org/10.1128/JCM.03461-12.
10. Goldenberg SD, Finn J, Sedudzi E, et al. Performance of the GeneXpert CT/NG
assay compared to that of the Aptima AC2 assay for detection of rectal
Chlamydia trachomatis and Neisseria gonorrhoeae by use of residual Aptima
samples. J Clin Microbiol 2012; 50(12):38679.
http://dx.doi.org/10.1128/JCM.01930-12.
11. Huang W, Gaydos CA, Barnes MR, et al. Comparative effectiveness of a rapid
point-ofcare test for detection of Chlamydia trachomatis among women in a
clinical setting. Sex Transm Infect 2013;89(2):10814.
http://dx.doi.org/10.1136/sextrans-2011-050355.
12. Hui BB, Wilson DP, Ward JS, et al. The potential impact of new generation
molecularpoint-of-care tests on gonorrhoea and chlamydia in a setting of high
endemic prevalence. Sex Health 2013;10(4):34856.
http://dx.doi.org/10.1071/SH13026.
13. Jenkins WD, Zahnd W, Kovach R, Kissinger P. Chlamydia and gonorrhea
screening in United States emergency departments. J Emerg Med
2013;44(2):55867. http://dx.doi.org/10.1016/j.jemermed.2012.08.022. Levitt
MA, Johnson S, Engelstad L, et al. Clinical management of chlamydia and
gonorrhea infection in a county teaching emergency departmentconcerns in
overtreatment, undertreatment, and follow-up treatment success. J Emerg Med
2003;25(1):711. http://dx.doi.org/10.1016/S07364679(03)00138.
14. May L,Ware CE, Jordan JA, et al. A randomized controlled trial comparing the
treatment of patients tested for chlamydia and gonorrhea after a rapid
polymerase chain reaction test versus standard of care testing. Sex Transm Dis
2016;43(5):2905. http://dx.doi.org/10.1097/OLQ.0000000000000438.
15. Parta M, GoebelM, Thomas J, et al. Impact of an assay that enables rapid
determination of Staphylococcus species and their drug susceptibility on the
treatment of patients with positive blood culture results. Infect Control Hosp
Epidemiol 2010;31(10):10438. http://dx.doi.org/10.1086/656248.
16. Society for Healthcare Epidemiology of America, Infectious Diseases Society of
America, Pediatric Infectious Diseases Society. Policy statement on
antimicrobial stewardship by the Society for Healthcare Epidemiology of
America, the Infectious Diseases Society of America, and the Pediatric
Infectious Diseases Society. Infect Control Hosp Epidemiol 2012;33(4):227.
http://dx.doi.org/10.1086/665010.
17. Tabrizi SN, Unemo M, Golparian D, et al. TTANGO investigators. Analytical
evaluation of GeneXpert CT/NG, the first genetic point-of-care assay for
simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis. J
Clin Microbiol 2013;51(6): 19457. http://dx.doi.org/10.1128/JCM.00806-13.
18. Turner KM, Round J, Horner P, et al. An early evaluation of clinical and
economic costs and benefits of implementing point of care NAAT tests for
Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine
clinics in England. Sex Transm Infect 2014;90(2):10411.
http://dx.doi.org/10.1136/sextrans-2013-051147.
19. U.S. Department of Health and Human Services Centers for Disease Control and
Prevention. Antibiotic resistance threats in the United States, 2013. Available at:
http://www.cdc.gov/drugresistance/threat-report-2013, 2014. [Accessed May 3,
2016].
Dampak Uji Diagnostik Cepat untuk Klamidia dan Gonore pada Pemanfaatan
Antimikroba yang Tepat di Departemen Gawat Darurat
Abstrak
Latar Belakang: Hasil test Neisseria gonorrhea (NG) dan Chlamydia trachomantis
(CT) yang berlangsung lama dan berulang dapt memperlambat pemberitahuan dan
pengobatan pada pasien tes-positif dan mengakibatkan penggunaan antimikrobial tidak
dibutuhkan pada pasien dengan hasil tes-negatif. Studi kuasi eksperimental ini
mengevaluasi dampak dari uji diagnostik cepat atau rapid diagnostic test (RDT) NG/CT
di departemen gawat darurat atau emergency department (ED) perkotaan mengenai
kesesuaian pengobatan, waktu pemberitahuan, dan biaya. Pasien diuji pada Desember
2013-Januari 2014 (kelompok tradisional, n = 200) dibandingkan dengan pasien pada
Desember 2014-Januari 2015 (kelompok RDT, n = 200). Terdapat peningkatan yang
signifikan pada kesesuaian pengobatan di kelompok RDT, 72.5% melawan 60% (P =
0.008) dan waktu untuk hasil pemberitahuan lebih cepat secara signifikan (median 17.4
dibanding 51.5 jam, P = 0.010). Ketersediaan hasil uji sebelum pemulangan pasien
berkaitan dengan peningkatan kesesuaian pengobatan (rasio odds, 22.65 [interval
kepercayaan 95%, 2.86179.68]). RDT akan menghemat sekitar $37,000 pertahun.
Hasil ini mendukung penggunaan RDT NG/CT untuk memperluas upaya pengelolaan
antimikroba pada ED
Pendahuluan
4. Seleksi peserta
Laporan yang dihasilkan komputer dari rekam medis elektronik
digunakan secara retrospektif mengidentifikasi semua pasien yang diuji NG / CT
selama masa studi. Data yang dikumpulkan meliputi karakteristik pasien,
karakteristik pengujian, terapi antimikroba yang diberikan, kesesuaian
pengobatan awal, waktu untuk menguji hasil, pemberitahuan waktu terhadap
pasien hasil test-positif, waktu untuk pengobatan yang sesuai, dan lama rawatan
ED.
Kelompok uji tradisional terdiri dari 200 pasien berturut-turut yang hadir
ke ED antara 1 Desember 2013 dan 31 Januari 2014. Pasien yang diujicobakan
untuk NG / CT dipertimbangkan untuk perawatan empiris sebelum
diberhentikan berdasarkan pertimbangan penyedia (Centers for Disease Control
and Prevention, 2015b). Setelah hasil tes didapat, petugas ED memberi tahu
pasien yang dinyatakan hasil test positif NG / CT dan memberikan konseling
dan edukasi melalui telepon. Pasien yang tidak menerima pengobatan empiris
diberikan perawatan dengan resep dengan telepon atau dengan permintaan untuk
kembali ke ED untuk pemberian antimikroba parenteral. Jika pasien tidak dapat
dihubungi setelah melakukan 3 upaya telepon, sebuah surat bersertifikat
dikirimkan ke pasien dan informasi pasien diteruskan ke departemen kesehatan
kabupaten untuk ditindaklanjuti.
RDT dilaksanakan dan digunakan di ED pada bulan Oktober 2014.
Kelompok RDT terdiri dari 200 pasien berturut-turut yang hadir ke ED antara 1
Desember 2014 dan 31 Januari 2015. Jika hasilnya tersedia sebelum pasien
pulang, pasien dengan hasil positif diberi pemberitahuan, konseling, dan
pengobatan untuk NG / CT saat berada di ED. Pasien test-negatif diberi tahu dan
melarang pemberian antimikroba yang tidak perlu. Jika pasien sudah siap untuk
dipulangkan sebelum penyelesaian hasil RDT, penyedia memiliki pilihan untuk
memberi perawatan empiris kepada pasien dan memungkinkan tindak lanjut
hasilnya setelah dikeluarkan. Penyedia tidak dianjurkan untuk menunda
pemulangan pasien agar dapat menunggu hasil RDT. Staf ED akan
menghubungi pasien dengan hasil positif untuk pemberitahuan, konseling, dan
mengikuti perawatan proses yang sama dengan tes tradisional. Pada kedua
kelompok, pasien juga diskrining dan diobati untuk IMS tambahan (mis.,
Trikomonas) jika ada indikasi
5. Hasil
Poin utama penelitian ini adalah untuk membandingkan persentase
pasien yang mendapat pengobatan yang tepat selama indeks kunjungan ke ED
dengan menggunakan tes tradisional dibandingkan RDT untuk NG / CT.
Pengobatan yang tepat didefinisikan sebagai titik akhir gabungan pasien positif
tes yang menerima terapi antimikroba sesuai dengan pedoman CDC 176 K.R.
Rivard et al. / Diagnostic Microbiology and Infectious Disease 87 (2017) dan
pasien tes negatif tidak mendapatkan pengobatan antimikroba.
Poin sekunder termasuk waktu untuk menguji hasil, waktu sampai
pemberitahuan pasien tentang hasil tes positif, dan waktu untuk pengobatan
yang tepat. Waktu untuk menguji hasilnya dihitung saat laboratorium menerima
sampel sampai saat hasil tes diunggah ke rekam medis. Waktu untuk
pemberitahuan pasien tentang hasil tes positif dihitung saat hasil NG / CT
tersedia pada saat pemberitahuan pasien didokumentasikan dalam catatan medis.
Waktu untuk pengobatan yang tepat untuk pasien dengan tes positif dihitung
saat hasil NG / CT tersedia pada saat terapi antimikroba yang tepat diberikan.
Pemberian terapi antimikroba yang tepat termasuk pemberian obat awal di ED,
masuk kembali ke ED untuk perawatan, atau resep telepon. Analisis biaya
dilakukan dengan menggunakan data keuangan institusional untuk menentukan
biaya rata-rata perlakuan yang tepat dan tidak tepat pada kedua kelompok. Biaya
diperoleh dengan menggunakan biaya langsung ke institusi tes, biaya kunjungan
ED dan ditinjau kembali berdasarkan kode diagnosis, dan biaya antimikroba
.
6. Analisis
Penelitian ini didukung untuk mendeteksi perbedaan mutlak 15% pada
pengobatan antimikroba awal yang tepat dengan menggunakan uji 2 sisi dengan
= 0,05 dan = 0,2. Ukuran efek 15% dipilih berdasarkan literatur sebelumnya
yang mengevaluasi integrasi RDT menjadi program pengelolaan antimikroba
(Clerc et al., 2013; Parta et al., 2010). Dipastikan bahwa 167 pasien di masing-
masing kelompok perlu disertakan dalam penelitian ini. Data percontohan dari
lokasi penelitian menemukan bahwa sekitar 125 pasien per bulan diujicobakan,
oleh karena itu, 2 bulan dimasukkan ke dalam masing-masing kelompok dengan
jumlah pendaftaran maksimal 200 pasien per kelompok (n = 400).
Untuk semua karakteristik dasar dan poin akhir studi, data kategoris
dibandingkan dengan uji chi square atau uji Fisher exact; Data kontinyu
dibandingkan dengan uji t Student atau uji Mann-Whitney U. Analisis regresi
logistik multivariat dilakukan untuk menentukan variabel yang relevan secara
klinis yang terkait secara independen dengan kelayakan pengobatan. Semua
variabel yang terkait dengan terapi yang sesuai dalam analisis bivariat (P b 0,2)
dipertimbangkan untuk dimasukkan ke dalam model multivariat. Data yang
masuk diteruskan dan digunakan untuk mendapatkan model akhir untuk terapi
yang tepat. Variabel signifikan pada model akhir adalah P b 0,05. Uji statistik
dilakukan dengan menggunakan SPSS 21.0 (SPSS, Chicago, IL)
Hasil
2. Hasil utama
Pengobatan awal dianggap tepat pada 60% pasien pada kelompok
tradisional dibandingkan dengan 72,5% pada kelompok RDT (P = 0.008, Table
1). Perbedaan ini didorong oleh pasien tes-negatif yang tidak diberi terapi
antimikroba. Untuk pasien tes-positif, pengobatan empiris diberikan secara tepat
pada indeks kunjungan ED pada 15 pasien (78,9%) pada kelompok tradisional
dan 18 pasien (90%) pada kelompok RDT (P = 0,407). Waktu rata-rata untuk
menguji hasil secara signifikan menurun pada kelompok RDT dibandingkan
dengan kelompok tradisional (2,4 [1,4-12,0] dibanding 31,7 [9,7-105,9] jam, P b
0,001), seperti juga waktu untuk pemberitahuan pasien tentang hasil positif (17,4
[0,0-93,0] dibanding 53,7 [26,9-79,9] jam, P = 0,010). Dari catatan, ada 2 pasien
dalam kelompok tradisional (semua diobati secara empiris) dan 7 di kelompok
RDT (5 diobati secara empiris) yang tidak dapat diberi tahu tentang hasil tes
positif mereka melalui telepon (P = 0,092). Tidak ada perbedaan waktu yang
signifikan secara statistik untuk menguji sampel pasien atau lamanya berada di
ED (Table 1).
Rata-rata waktu untuk pengobatan yang tepat untuk pasien uji
positif pada kelompok tradisional adalah 23,0 56,3 jam. Lima belas
pasien (78,9%) diobati secara empiris pada kunjungan ED awal dan 4
(21,1%) memerlukan tindak lanjut untuk pemberian pengobatan. Dari
mereka yang memerlukan perawatan setelah pemulangan, 2 (10,5%)
pasien diminta untuk kembali ke DE untuk pengobatan NG. Waktu rata-
rata untuk pengobatan yang tepat pada kelompok RDT adalah 4,9 21,3
jam. Semua pasien di kelompok RDT dirawat sebelum pemulangan di
ED atau hilang saat di follow-up; 5 pasien (25%) secara definitif diobati
pada kunjungan ED awal (hasil positif tersedia sebelum dikeluarkan dan
digunakan untuk terapi langsung), 13 (65%) diobati secara empiris pada
kunjungan ED awal, dan 2 (10%) tidak dapat dihubungi melalui telepon
dan memerlukan follow-up Departemen kesehatan kabupaten. Tidak ada
pasien di kelompok RDT yang meminta pendaftaran kembali untuk
perawatan. Pengujian melalui RDT dikaitkan dengan penghematan biaya
$ 4891 ($ 24,46 per pasien) dibandingkan dengan pengujian tradisional
selama studi ($ 343.566 dibanding $ 348.457).
Sepuluh variabel dipilih untuk regresi logistik multivariat untuk
menguji faktor-faktor yang terkait secara independen dengan perlakuan
yang tepat (Table 2). Satu-satunya faktor yang terkait secara positif
dengan kelayakan pengobatan adalah tersedianya hasil tes NG / CT
sebelum dipulangkan (Rasio odds [OR], 22,65 [interval kepercayaan
95% {CI}, 2,86-179,68, P = 0,003]). Secara total, 40 pasien di kelompok
RDT dapat diberitahu tentang hasil tes mereka sebelum dipulangkan.
Dari pasien ini, ada 5 tes-positf dan 100% pasien ini mendapat
pengobatan yang tepat. Dari 35 pasien tes-negatif, 34 tidak diberi
antimikroba yang tidak perlu. Satu pasien dirawat meski mendapat hasil
negatif karena pasien tersebut adalah pekerja seks komersial yang
melaporkan dirinya. Pasien yang melaporkan gejala genital discharge
lebih mungkin untuk menerima pengobatan yang tidak tepat (OR, 0.42
[95% CI, 0.260.68, P b 0.001]).
Diskusi
Referensi
1. Centers for Disease Control and Prevention (CDC). Recommendations for the
laboratorybased detection of Chlamydia trachomatis and Neisseria
gonorrhoeae2014. MMWRRecomm Rep 2014;63(RR-02):119.
2. Centers for Disease Control and Prevention (CDC). Gonorrhea CDC fact sheet
(detailed version). Available at: http://www.cdc.gov/std/gonorrhea/stdfact-
gonorrhea-detailed.htm, 2015. [Accessed May 3, 2016].
3. Centers for Disease Control and Prevention (CDC). Sexually transmitted
diseases treatment guidelines, 2015. MMWR Recomm Rep 2015b;64(RR-03):1
137.
4. Centers for Disease Control and Prevention (CDC). Chlamydia CDC fact sheet
(detailed version). Available at: http://www.cdc.gov/std/chlamydia/stdfact-
chlamydia-detailed.htm. [Accessed May 3, 2016].
5. Centers for Disease Control and Prevention (CDC). Reported STDs in the
United States: 2014 National Data for Chlamydia, Gonorrhea, And Syphilis.
Available at: http://www.cdc.gov/std/stats14/std-trends-508.pdf. [Accessed May
3, 2016].
6. Centers for Disease Control and Prevention National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention. Sexually transmitted diseases
surveillance 2013. Available at: http://www.cdc.gov/std/stats13/surv2013-
print.pdf. [Accessed May 3, 2016].
7. Cepheid. Xpert CT/NG: package insert. Sunnyvale, CA: Cepheid; 2015. Clerc
O, Prod'hom G, Vogne C, et al. Impact of matrix-assisted laser desorption
ionization time-of-flight mass spectrometry on the clinical management of
patients with gramnegative bacteremia: a prospective observational study. Clin
Infect Dis 2013;56(8): 11017. http://dx.doi.org/10.1093/cid/cis1204.
8. Dellit TH, Owens RC, McGowan Jr JE, et al. Infectious Diseases Society of
America; Society for Healthcare Epidemiology of America. Infectious Diseases
Society of America and the Society for Healthcare Epidemiology of America
guidelines for developing an institutional program to enhance antimicrobial
stewardship. Clin Infect Dis 2007; 44(2):15977.
http://dx.doi.org/10.1086/510393.
9. Gaydos CA, Van Der Pol B, Jett-Goheen M, et al, CT/NG Study Group.
Performance of the Cepheid CT/NG Xpert rapid PCR test for detection of
chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol
2013;51(6):166672. http://dx.doi.org/10.1128/JCM.03461-12.
10. Goldenberg SD, Finn J, Sedudzi E, et al. Performance of the GeneXpert CT/NG
assay compared to that of the Aptima AC2 assay for detection of rectal
Chlamydia trachomatis and Neisseria gonorrhoeae by use of residual Aptima
samples. J Clin Microbiol 2012; 50(12):38679.
http://dx.doi.org/10.1128/JCM.01930-12.
11. Huang W, Gaydos CA, Barnes MR, et al. Comparative effectiveness of a rapid
point-ofcare test for detection of Chlamydia trachomatis among women in a
clinical setting. Sex Transm Infect 2013;89(2):10814.
http://dx.doi.org/10.1136/sextrans-2011-050355.
12. Hui BB, Wilson DP, Ward JS, et al. The potential impact of new generation
molecularpoint-of-care tests on gonorrhoea and chlamydia in a setting of high
endemic prevalence. Sex Health 2013;10(4):34856.
http://dx.doi.org/10.1071/SH13026.
13. Jenkins WD, Zahnd W, Kovach R, Kissinger P. Chlamydia and gonorrhea
screening in United States emergency departments. J Emerg Med
2013;44(2):55867. http://dx.doi.org/10.1016/j.jemermed.2012.08.022. Levitt
MA, Johnson S, Engelstad L, et al. Clinical management of chlamydia and
gonorrhea infection in a county teaching emergency departmentconcerns in
overtreatment, undertreatment, and follow-up treatment success. J Emerg Med
2003;25(1):711. http://dx.doi.org/10.1016/S07364679(03)00138.
14. May L,Ware CE, Jordan JA, et al. A randomized controlled trial comparing the
treatment of patients tested for chlamydia and gonorrhea after a rapid
polymerase chain reaction test versus standard of care testing. Sex Transm Dis
2016;43(5):2905. http://dx.doi.org/10.1097/OLQ.0000000000000438.
15. Parta M, GoebelM, Thomas J, et al. Impact of an assay that enables rapid
determination of Staphylococcus species and their drug susceptibility on the
treatment of patients with positive blood culture results. Infect Control Hosp
Epidemiol 2010;31(10):10438. http://dx.doi.org/10.1086/656248.
16. Society for Healthcare Epidemiology of America, Infectious Diseases Society of
America, Pediatric Infectious Diseases Society. Policy statement on
antimicrobial stewardship by the Society for Healthcare Epidemiology of
America, the Infectious Diseases Society of America, and the Pediatric
Infectious Diseases Society. Infect Control Hosp Epidemiol 2012;33(4):227.
http://dx.doi.org/10.1086/665010.
17. Tabrizi SN, Unemo M, Golparian D, et al. TTANGO investigators. Analytical
evaluation of GeneXpert CT/NG, the first genetic point-of-care assay for
simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis. J
Clin Microbiol 2013;51(6): 19457. http://dx.doi.org/10.1128/JCM.00806-13.
18. Turner KM, Round J, Horner P, et al. An early evaluation of clinical and
economic costs and benefits of implementing point of care NAAT tests for
Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine
clinics in England. Sex Transm Infect 2014;90(2):10411.
http://dx.doi.org/10.1136/sextrans-2013-051147.
19. U.S. Department of Health and Human Services Centers for Disease Control and
Prevention. Antibiotic resistance threats in the United States, 2013. Available at:
http://www.cdc.gov/drugresistance/threat-report-2013, 2014. [Accessed May 3,
2016]