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Adrienne Rain Mocello, MPH

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1 California Gonorrhea Surveillance System: Sample-Based Collection of Surveillance Data
Adrienne Rain Mocello, MPH Michael C. Samuel, DrPH, K. Jayne Bradbury, MPH, Romni A. Neiman, Edwin Lopez, Joe L. Sanchez, Gail Bolan, MD California Department of Public Health STD Control Branch 2008 National STD Prevention Conference March 12, 2008 Hello, my name is Rain Mocello. I am an epidemiologist at the STD Control Branch of the CA Dept. of Public Health, and I will be discussing the California Gonorrhea Surveillance System and sample-based collection of surveillance data.

2 BACKGROUND Gonorrhea Surveillance in California
Gonorrhea (GC) case definition Follows CDC case definition Case excluded if GC diagnosis w/in previous 30 days Passive reporting system Confidential Morbidity Report (CMR) from provider and/or lab report Variables on CMR and lab report differ Race/ethnicity Treatment data Case contact information I’ll start with some background on gonorrhea surveillance in California. The State’s gonorrhea case definition follows that of the CDC, including “any written morbidity report of gonorrhea submitted by a physician”. Any case with a gonorrhea diagnosis within the previous 30 days is excluded. Routine gonorrhea surveillance is based on a passive reporting system in which providers submit a Confidential Morbidity Report to the local health department for each case diagnosed; in parallel, testing laboratories submit a lab report for each case. Different variables are contained on the CMR and lab report. Labs do not report data on race/ethnicity or treatment and often contain incomplete case contact information.

3 BACKGROUND Gonorrhea Rates in California
Rates of GC in California declined from the late 1970s until they started to rise in 2000 Causes for increases are not fully understood Since 2004, more than 30,000 cases have been reported annually Insufficient Disease Intervention Specialist resources to follow up with all cases I’ll start with some background on gonorrhea surveillance in California. The State’s case definition of a gonorrhea case follows the CDC definition, including “any written morbidity report of gonorrhea submitted by a physician”. Any case with a gonorrhea diagnosis within the previous 30 days is excluded. Routine gonorrhea surveillance is based on a passive reporting system in which providers submit a Confidential Morbidity Report to the local health department for each case diagnosed; in parallel, testing laboratories generate and submit a lab report for each case. Different variables are contained on the CMR and lab report. Labs do not report data on race/ethnicity or treatment and often contain incomplete case contact information.

4 RATIONALE Improving Gonorrhea Surveillance
CMR surveillance collects only a small set of basic demographic variables These data are not adequate to describe factors associated with changing trends Incomplete data are reported on treatment No behavioral data are collected on number and gender of sex partners, drug use, and other risk factors In order to better understand risk factors associated with increasing rates, improvements were needed to California case-based gonorrhea surveillance in the following areas: CMR surveillance collects only a small set of basic demographic variables. These data are not adequate to describe factors associated with changing trends. Incomplete data are reported on treatment, which is particularly important to monitor in light of recent changes to treatment guidelines. In addition, no behavioral risk data are available on number and gender of sex partners, drug use, and other risk factors.

5 CALIFORNIA GONORRHEA SURVEILLANCE SYSTEM
Implemented statewide in January 2007 Ongoing data collection provides trend data on risk factors A sustainable workload is maintained through the use of a random sampling scheme Relevant risk factor information is collected that can lead to programmatic action Therefore, the California Gonorrhea Surveillance System was developed with the following characteristics in mind: Ongoing data collection provides trend data on risk factors A sustainable workload is maintained for local programs through the use of a random sampling scheme. Relevant risk factor information is collected that can lead to programmatic action. And results are regularly disseminated to stakeholders.

6 METHODS I Case Investigation Record (CIR) Provider Report Form
Symptom status, specimen source, and treatment Fax/telephone/chart review Patient Interview Form Demographic info Sexual behaviors, drug use, and venues used to meet new/anonymous sex partners Telephone or in-person This Statewide gonorrhea case report surveillance system was fully implemented by January of 2007. The data collection tool designed for the system is the Case Investigation Record, which is administered by local health jurisdiction staff or State DIS. The Case Investigation Record has two main components: The Provider Report Form collects data from providers on symptom status, specimen source, and treatment, and is primarily used as a fax-back form. Alternately, it can be completed over the telephone or through chart review. The Patient Interview Form solicits detailed demographic information, as well as data on sexual behaviors, drug use, and venues used to meet new or anonymous sex partners. This component is typically completed through telephone interview but may be administered in-person. The overall goal for the system is to capture data on a 10% random sample of reported gonorrhea cases. However, jurisdictions were given the choice of investigating 10% or 100% of their cases, both to enable them to tailor their participation to their local capacity and to allow smaller jurisdictions sufficient data for meaningful local analysis. Data are weighted for analysis to account for this variable sampling scheme.

7 METHODS II Case selection Data weighted for analysis
Goal – to follow up with 10% of reported gonorrhea cases Jurisdictions choose sampling fraction 10% random sample 100% of reported cases Data weighted for analysis Results sent to stakeholders quarterly This Statewide gonorrhea case report surveillance system was fully implemented by January of 2007. The data collection tool designed for the system is the Case Investigation Record, which is administered by local health jurisdiction staff or State DIS. The Case Investigation Record has two main components: The Provider Report Form collects data from providers on symptom status, specimen source, and treatment, and is primarily used as a fax-back form. Alternately, it can be completed over the telephone or through chart review. The Patient Interview Form solicits detailed demographic information, as well as data on sexual behaviors, drug use, and venues used to meet new or anonymous sex partners. This component is typically completed through telephone interview but may be administered in-person. The overall goal for the system is to capture data on a 10% random sample of reported gonorrhea cases. However, jurisdictions were given the choice of investigating 10% or 100% of their cases, both to enable them to tailor their participation to their local capacity and to allow smaller jurisdictions sufficient data for meaningful local analysis. Data are weighted for analysis to account for this variable sampling scheme.

8 Case Selection and Flow of Data
10% Sample n=34 100% Follow-Up n=27 + GC reported to local health jurisdiction by lab report and/or CMR Case reported to the State Case Investigation Record (CIR) initiated by local staff Data analyzed by State and returned to local jurisdictions Weekly random sample taken at the State 8 week interview window 8 contact attempts 2 on evenings 2 on weekend Completed CIR mailed to State and entered Pre-populated CIR sent to local health jurisdiction The case selection process begins when a case is reported to the local health department. 27 out of 61 jurisdictions elected to interview 100% of their cases. These are generally smaller, more rural counties, and report roughly 5% of all gonorrhea cases in California annually. For each case that is reported to the health department, local staff initiate a Case Investigation Record and proceed with patient and provider follow-up. For those 34 jurisdictions choosing the 10% option, cases are reported to the State on a weekly basis. From this pool of newly reported cases, a random sample is run weekly by the State. These jurisdictions then receive, via secure , a Case Investigation Record for each case, which is partially pre-populated with case and provider contact information. At this point local staff initiate follow-up. All jurisdictions have an 8-week window from the date of specimen collection in which to conduct the investigation. During that time they are required to make a minimum of 8 contact attempts, including 2 during evening hours and 2 on the weekend. At the end of the 8-week window, each form is mailed to the State for data entry. Data are analyzed quarterly and results sent to our local partners. Local line list data are also provided to those jurisdictions interested in conducting their own analyses. CIR initiated by local staff Patient and provider follow-up begin

9 System Performance Feedback provided to jurisdictions monthly
Timeliness of reporting Number of forms completed Response rates Quality control Demographics of sampled and interviewed cases are compared with those of all reported cases Feedback on performance is given to jurisdictions monthly, including statistics on timeliness of reporting, which is essential to maximize the amount of time available to interview cases; on the number of forms completed; and on the proportion of cases interviewed. For quality control, the demographics of sampled and interviewed cases are compared with those of all reported cases.

10 Flow of Cases, 1/1/07 – 9/30/07 Reported Cases N = 23,887
100% Jurisdictions n = 1,355 10% Jurisdictions n = 22,532 Cases sampled n = 2,905 Forms received n = 1,247 Forms received n = 2,151 This shows the flow of cases from January 1st through September 30th, 2007. Roughly 24,000 cases were reported during that period, 1355 of which were in jurisdictions interviewing 100% of their cases cases were sampled from jurisdictions participating at the 10% level. The relatively well-balanced number of cases from large versus small jurisdictions demonstrates the efficiency of this sampling scheme, resulting in greater precision of estimates and the ability to conduct county-level analysis. Of those eligible cases for which an interview record has been entered, 805 have been successfully interviewed in the 100% group, and 1230 in the 10% group, resulting in an overall interview rate of 61.4%. Our goal is 80%, and the response rate has been improving as jurisdictions have become more familiar with the system. Eligible for interview n = 1,226 Eligible for interview n = 2,089 Interview completed n = 805 Interview completed n = 1,230

11 Response Rate Overall response rate was 61.4%
Slightly higher among jurisdictions following up with all cases Target response rate is 80% Main reasons for non-interview Lack of adequate case contact information Case non-response Once contacted, cooperation rate was 91.3% Of the 421 cases from the 100% group that were not successfully interviewed, the two main reasons were lack of adequate patient contact data and no patient response within 8 weeks or 8 attempts. For the 859 non-interviewed cases from the 10% jurisdictions, the same main reasons for non-interview were found. However, overall, once a case was contacted, most were willing to participate, resulting in a cooperation rate of over 91%. In the event that a case is not interviewed, provider data are still collected, allowing most cases to be included in the analysis of certain key variables, such as treatment.

12 RESULTS Gender and Sexual Orientation by Region
I’ll now move on to some of our findings. All analyses were performed using weighted data from cases diagnosed between January 1st and September 30th, 2007. This table shows the distribution of gender and sexual orientation among interviewed gonorrhea cases stratified by geographic region. As you can see, the proportion of cases in each stratum of sexual orientation varies by region, with only 8.1% of Northern California cases self-identified as men who have sex with men, compared with 22.1% in Southern California and 78.8% in San Francisco. This information is vital for understanding the local epidemiology of gonorrhea and for intervention planning. California Gonorrhea Surveillance System, Weighted data, 1/1/07 – 9/30/07

13 Selected Risk Characteristics
Greater Internet use reported by MSM Higher proportions of incarceration among heterosexual men and women Reported meth use varied by sexual orientation and race/ethnicity: The majority of HIV co-infections were among MSM; 27.4% of interviewed MSM reported being HIV+ Analysis of California Gonorrhea Surveillance System data generated some key results consistent with those seen from other sources, with greater Internet use to meet new or anonymous sex partners reported by men who have sex with men and higher proportions of incarceration in the past 12 months among heterosexual men and women. In addition, the variables collected through this system enable detailed stratification not possible using other data sources. Meth use varied significantly by sexual orientation and race/ethnicity, with white cases reporting the highest proportion among MSM at 20.7% and heterosexual African American cases reporting dramatically lower Meth use, 3.6% among heterosexual men and 1.6% in women. And finally, we looked at self-reported HIV co-infection. The vast majority of HIV co-infected gonorrhea cases were among men who have sex with men, at 28.4% HIV positive. California Gonorrhea Surveillance System, Weighted data, 1/1/07 – 9/30/07

14 Fluoroquinolone Use by Setting of Diagnosis
Another issue that has been crucial in California for several years are changes to treatment guidelines in response to the emergence of fluoroquinolone-resistant gonorrhea and the impact of those changes on treatment patterns among providers. This table show the number and percent of interviewed cases diagnosed in each health care setting. The rightmost column shows the proportion of cases within each setting who were treated with only a fluoroquinolone. The majority of cases were diagnosed by a private physician or HMO, where 7% of cases were treated exclusively with a fluoroquinolone. Other settings with high fluoroquinolone use include urgent care clinics and emergency rooms. And overall, almost 4% of interviewed cases were treated inadequately. These data provide guidance on where educational efforts are needed to inform California health care providers of current treatment guidelines. California Gonorrhea Surveillance System, Weighted data, 1/1/07 – 9/30/07

15 CONCLUSIONS Sample-based surveillance is an efficient means to gather important data, especially when the total volume of morbidity precludes follow-up with all cases The use of telephone-based interviews and fax-back forms allow even greater efficiency Data have yielded valuable guidance on targeted interventions for disease prevention provider education In conclusion, sample-based surveillance is an efficient and reliable means to gather important data when the total volume of morbidity precludes follow-up with all cases. Telephone-based interviews allow even greater efficiency and overall, these methods have enabled our local partners to successfully add this system to their workload. Results from our first year of data collection have provided valuable direction on areas for targeted interventions for disease prevention and provider education.

16 LIMITATIONS Reporting delays and inadequate case contact info contributed to low response rates Competing priorities for STD follow-up cause challenges in resource allocation Field staff unaccustomed to interview style Incomplete data There have been some bumps in the road, in particular with reporting delays and inadequate case contact information These have contributed to lower-than-target response rates. In addition, competing priorities for STD follow-up cause challenges with resource allocation. When available, State DIS assist jurisdictions with surge capacity for their gonorrhea interviews to mitigate this problem. Because historically the emphasis in California has been on syphilis control, some field staff are unaccustomed to this different interview style, that has a main focus on an interview with data collection rather than case management. This has resulted in incomplete data fields, which we are continuing to work to improve.

17 Contact Information Adrienne Rain Mocello, MPH (510) Acknowledgments Local program partners State DIS staff and managers Denise Gilson, California Dept. of Public Health CDC OASIS Project I’m happy to answer any questions now. Please also feel free to contact me directly. I would like to acknowledge all of our local partners; Denise Gilson, the project data manager, whose patience and expertise have been a critical component of the continued success of this system; and the CDC OASIS Project. Thank you.


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